Re: Reducing Noritate Useage

[Guest guest]

> After six weeks of initial use, I am pleased to say that Noritate

> has reduced the appearance of my rosacea by 30 to 40 percent. My

> doctor said that I could try tapering off application of Noritate

> from once a day to every so many days or just on the days that I

> had flares. Has anyone using Noritate seen complete improvement?

> Have you reduced your application of it from daily use?

A 1998 study from the University of Minnesota addresses your

concerns, albeit indirectly. This was a multi-center, randomized,

double-blind, placebo control study (the most rigorous study design

study in clinical research); although it only used one formulation of

topical metronidazole, other studies suggest its results can be

generalized to all formulations, including Noritate. I've pasted the

abstract below.

Regarding complete improvement: out of 113 patients with moderate-to-

severe rosacea, 88 (78%) responded with a signficant (70%) reduction

in inflammation and 67 (59%) had complete cessation of symptoms using

both oral antibiotics and topical metronidazole gel. (You didn't

mention taking oral antibiotics, although it's not clear whether

adding oral antibiotics to well-tolerated topical therapy adds much

in the long run). I don't recall the length of time these patients

were treated, although your time course of 6 weeks is on the short

side for initial treatment (usually 6-12 weeks). Finally, the study's

definition of moderate-to-severe rosacea may not match your clinical

condition.

A less academically rigorous study was published this past November

in the Journal of American Academy of Dermatology. Those researchers

found that out of 70 patients (requiring more severe rosacea for

entry than the above study), almost half had a " clear to mild

condition " after 12 weeks of just topical metronidazole treatment.

So, based on these studies, after an initial course of therapy with

antibiotics, topical with/without oral, about 75% had significant

improvement and about half had complete or near-complete reversal of

rosacea symptoms.

How many continue to do well after initial treatment? That's the

heart of the University of Minnesota study. Within six months,

continuing topical metronidazole reduced the occurrence and severity

of relapse in about half of those who relapsed. But note that over

half of these moderate-severe patients not using prophylactic topical

metronidazole did not relapse during the study's 6 months; I'm not

aware of studies that look at chronic prophylatic topical

metronidazole beyond six months, but retreatment may be a preferred

option for patients who relapse less than twice a year.

You might discuss these results with your physician, to see if

continuing with once-daily Noritate for the full initial treatment

course of 12 weeks will provide for maximum improvement of your

symptoms beyond 30-40%. After initial therapy, it's not unreasonable

for your doctor to recommend tapering treatment to see how your skin

responds over time, eventually without any Noritate or using it just

as-needed, rather than committing you to once-daily treatment

indefinitely. As you say, the desert conditions may provide for

ongoing irritation to your rosacea. But if your skin is less inflamed

it may no longer be sensitive to these conditions.

You aren't my patient, and I'm an emergency physician not a

dermatologist, so please don't take anything I say as clinical advice

or treatment! That's not how the above information was intended at

all. I've had to educate myself on rosacea to help manage my own

symptoms, so the above is based on my understanding of the

literature, from my perspective. But I hope it helps. I thought your

questions were good ones.

Good luck.

Marjorie

Marjorie Lazoff, MD

Arch Dermatol 1998 Jun;134(6):679-83

Topical metronidazole maintains remissions of rosacea.

Dahl MV, Katz HI, Krueger GG, Millikan LE, Odom RB, F, Wolf JE

Jr, Aly R, Bayles C, Reusser B, Weidner M, E, Patrignelli R,

Tuley MR, Baker MO, Herndon JH Jr, Czernielewski JM.

Department of Dermatology, University of Minnesota, Minneapolis, USA.

BACKGROUND: cea is a chronic skin disease that requires long-term

therapy. Oral antibiotics and topical metronidazole successfully

treat rosacea. Because long-term use of systemic antibiotics carries

risks for systemic complications and adverse reactions, topical

treatments are preferred. OBJECTIVE: To determine if the use of

topical metronidazole gel (Metrogel) could prevent relapse of

moderate to severe rosacea. DESIGN: A combination of oral

tetracycline and topical metronidazole gel was used to treat 113

subjects with rosacea (open portion of the study). Successfully

treated subjects (n = 88) entered a randomized, double-blind, placebo-

controlled study applying either 0.75% topical metronidazole gel

(active agent) or topical metronidazole vehicle gel (placebo) twice

daily (blinded portion of the study). SETTING: Subjects were enrolled

at 6 separate sites in large cities at sites associated with major

medical centers. SUBJECTS: One hundred thirteen subjects with at

least 6 inflammatory papules and pustules, moderate to severe facial

erythema and telangiectasia entered the open phase of the study.

Eighty-eight subjects responded to treatment with systemic

tetracycline and topical metronidazole gel as measured by at least a

70% reduction in the number of inflammatory lesions. These subjects

were randomized to receive 1 of 2 treatments: either 0.75%

metronidazole gel or placebo gel. INTERVENTIONS: Subjects were

evaluated monthly for up to 6 months to determine relapse rates. MAIN

OUTCOME MEASURES: Inflammatory papules and pustules were counted at

each visit. Relapse was determined by the appearance of a clinically

significant increase in the number of papules and pustules.

Prominence of telangiectases and dryness (roughness and scaling) were

also observed. RESULTS: In the open phase, treatment with

tetracycline and metronidazole gel eliminated all papules and

pustules in 67 subjects (59%). The faces of 104 subjects (92%)

displayed fewer papules and pustules after treatment, and 82 subjects

(73%) exhibited less erythema. In the randomized double-blind phase,

the use of topical metronidazole significantly prolonged the disease-

free interval and minimized recurrence compared with subjects treated

with the vehicle. Eighteen (42%) of 43 subjects applying the vehicle

experienced relapse, compared with 9 (23%) of 39 subjects applying

metronidazole gel (P<.05). The metronidazole group had fewer papules

and/or pustules after 6 months of treatment (P<.01). Relapse of

erythema also occurred less often in subjects treated with

metronidazole (74% vs 55%). CONCLUSION: In a majority of subjects

studied, continued treatment with metronidazole gel alone maintains

remission of moderate to severe rosacea induced by treatment with

oral tetracycline and topical metronidazole gel.

PMID: 9645635 [PubMed - indexed for MEDLINE]

[Guest guest]

> After six weeks of initial use, I am pleased to say that Noritate

> has reduced the appearance of my rosacea by 30 to 40 percent. My

> doctor said that I could try tapering off application of Noritate

> from once a day to every so many days or just on the days that I

> had flares. Has anyone using Noritate seen complete improvement?

> Have you reduced your application of it from daily use?

A 1998 study from the University of Minnesota addresses your

concerns, albeit indirectly. This was a multi-center, randomized,

double-blind, placebo control study (the most rigorous study design

study in clinical research); although it only used one formulation of

topical metronidazole, other studies suggest its results can be

generalized to all formulations, including Noritate. I've pasted the

abstract below.

Regarding complete improvement: out of 113 patients with moderate-to-

severe rosacea, 88 (78%) responded with a signficant (70%) reduction

in inflammation and 67 (59%) had complete cessation of symptoms using

both oral antibiotics and topical metronidazole gel. (You didn't

mention taking oral antibiotics, although it's not clear whether

adding oral antibiotics to well-tolerated topical therapy adds much

in the long run). I don't recall the length of time these patients

were treated, although your time course of 6 weeks is on the short

side for initial treatment (usually 6-12 weeks). Finally, the study's

definition of moderate-to-severe rosacea may not match your clinical

condition.

A less academically rigorous study was published this past November

in the Journal of American Academy of Dermatology. Those researchers

found that out of 70 patients (requiring more severe rosacea for

entry than the above study), almost half had a " clear to mild

condition " after 12 weeks of just topical metronidazole treatment.

So, based on these studies, after an initial course of therapy with

antibiotics, topical with/without oral, about 75% had significant

improvement and about half had complete or near-complete reversal of

rosacea symptoms.

How many continue to do well after initial treatment? That's the

heart of the University of Minnesota study. Within six months,

continuing topical metronidazole reduced the occurrence and severity

of relapse in about half of those who relapsed. But note that over

half of these moderate-severe patients not using prophylactic topical

metronidazole did not relapse during the study's 6 months; I'm not

aware of studies that look at chronic prophylatic topical

metronidazole beyond six months, but retreatment may be a preferred

option for patients who relapse less than twice a year.

You might discuss these results with your physician, to see if

continuing with once-daily Noritate for the full initial treatment

course of 12 weeks will provide for maximum improvement of your

symptoms beyond 30-40%. After initial therapy, it's not unreasonable

for your doctor to recommend tapering treatment to see how your skin

responds over time, eventually without any Noritate or using it just

as-needed, rather than committing you to once-daily treatment

indefinitely. As you say, the desert conditions may provide for

ongoing irritation to your rosacea. But if your skin is less inflamed

it may no longer be sensitive to these conditions.

You aren't my patient, and I'm an emergency physician not a

dermatologist, so please don't take anything I say as clinical advice

or treatment! That's not how the above information was intended at

all. I've had to educate myself on rosacea to help manage my own

symptoms, so the above is based on my understanding of the

literature, from my perspective. But I hope it helps. I thought your

questions were good ones.

Good luck.

Marjorie

Marjorie Lazoff, MD

Arch Dermatol 1998 Jun;134(6):679-83

Topical metronidazole maintains remissions of rosacea.

Dahl MV, Katz HI, Krueger GG, Millikan LE, Odom RB, F, Wolf JE

Jr, Aly R, Bayles C, Reusser B, Weidner M, E, Patrignelli R,

Tuley MR, Baker MO, Herndon JH Jr, Czernielewski JM.

Department of Dermatology, University of Minnesota, Minneapolis, USA.

BACKGROUND: cea is a chronic skin disease that requires long-term

therapy. Oral antibiotics and topical metronidazole successfully

treat rosacea. Because long-term use of systemic antibiotics carries

risks for systemic complications and adverse reactions, topical

treatments are preferred. OBJECTIVE: To determine if the use of

topical metronidazole gel (Metrogel) could prevent relapse of

moderate to severe rosacea. DESIGN: A combination of oral

tetracycline and topical metronidazole gel was used to treat 113

subjects with rosacea (open portion of the study). Successfully

treated subjects (n = 88) entered a randomized, double-blind, placebo-

controlled study applying either 0.75% topical metronidazole gel

(active agent) or topical metronidazole vehicle gel (placebo) twice

daily (blinded portion of the study). SETTING: Subjects were enrolled

at 6 separate sites in large cities at sites associated with major

medical centers. SUBJECTS: One hundred thirteen subjects with at

least 6 inflammatory papules and pustules, moderate to severe facial

erythema and telangiectasia entered the open phase of the study.

Eighty-eight subjects responded to treatment with systemic

tetracycline and topical metronidazole gel as measured by at least a

70% reduction in the number of inflammatory lesions. These subjects

were randomized to receive 1 of 2 treatments: either 0.75%

metronidazole gel or placebo gel. INTERVENTIONS: Subjects were

evaluated monthly for up to 6 months to determine relapse rates. MAIN

OUTCOME MEASURES: Inflammatory papules and pustules were counted at

each visit. Relapse was determined by the appearance of a clinically

significant increase in the number of papules and pustules.

Prominence of telangiectases and dryness (roughness and scaling) were

also observed. RESULTS: In the open phase, treatment with

tetracycline and metronidazole gel eliminated all papules and

pustules in 67 subjects (59%). The faces of 104 subjects (92%)

displayed fewer papules and pustules after treatment, and 82 subjects

(73%) exhibited less erythema. In the randomized double-blind phase,

the use of topical metronidazole significantly prolonged the disease-

free interval and minimized recurrence compared with subjects treated

with the vehicle. Eighteen (42%) of 43 subjects applying the vehicle

experienced relapse, compared with 9 (23%) of 39 subjects applying

metronidazole gel (P<.05). The metronidazole group had fewer papules

and/or pustules after 6 months of treatment (P<.01). Relapse of

erythema also occurred less often in subjects treated with

metronidazole (74% vs 55%). CONCLUSION: In a majority of subjects

studied, continued treatment with metronidazole gel alone maintains

remission of moderate to severe rosacea induced by treatment with

oral tetracycline and topical metronidazole gel.

PMID: 9645635 [PubMed - indexed for MEDLINE]

[Guest guest]

Metronidazole _is_ the most proven treatment for cea. Thanks to

Galderma it has been tested, promoted and disseminated at large.

For those who can tolerate it, there is a reasonable likelihood that it

will give a reasonable benefit. Further there has been some results that

show long term maintenance with these topicals is a viable option.

Sadly many of the list members do not fall into this category - and hence

hang around wanting more. Those with severe rosacea, with strong contact

allergies, and with a strong vascular/flushing component to their rosacea

will find the metronidazole stories hollow.

I myself found rozex to be a reasonable treatment, but in the end it was

quite expensive and I found another regime that suited me better.

BTW it is still unknown how it works, it is not a typical antibiotic. Also

there is some promise that specially formulated ocular formulations of

metronidazole will be useful for ocular rosacea sufferers. The current

formulations are definitely _not_ for ocular use - it specifically warns

against it in the patient insert.

cheers,

davidp.

--

Pascoe, mailto:dp@..., South Perth, Western Australia

e>

>> After six weeks of initial use, I am pleased to say that Noritate

>> has reduced the appearance of my rosacea by 30 to 40 percent. My

>> doctor said that I could try tapering off application of Noritate

>> from once a day to every so many days or just on the days that I

>> had flares. Has anyone using Noritate seen complete improvement?

>> Have you reduced your application of it from daily use?

e> A 1998 study from the University of Minnesota addresses your

e> concerns, albeit indirectly. This was a multi-center, randomized,

e> double-blind, placebo control study (the most rigorous study design

e> study in clinical research); although it only used one formulation of

e> topical metronidazole, other studies suggest its results can be

e> generalized to all formulations, including Noritate. I've pasted the

e> abstract below.

e> Regarding complete improvement: out of 113 patients with moderate-to-

e> severe rosacea, 88 (78%) responded with a signficant (70%) reduction

e> in inflammation and 67 (59%) had complete cessation of symptoms using

e> both oral antibiotics and topical metronidazole gel. (You didn't

e> mention taking oral antibiotics, although it's not clear whether

e> adding oral antibiotics to well-tolerated topical therapy adds much

e> in the long run). I don't recall the length of time these patients

e> were treated, although your time course of 6 weeks is on the short

e> side for initial treatment (usually 6-12 weeks). Finally, the study's

e> definition of moderate-to-severe rosacea may not match your clinical

e> condition.

e> A less academically rigorous study was published this past November

e> in the Journal of American Academy of Dermatology. Those researchers

e> found that out of 70 patients (requiring more severe rosacea for

e> entry than the above study), almost half had a " clear to mild

e> condition " after 12 weeks of just topical metronidazole treatment.

e> So, based on these studies, after an initial course of therapy with

e> antibiotics, topical with/without oral, about 75% had significant

e> improvement and about half had complete or near-complete reversal of

e> rosacea symptoms.

e> How many continue to do well after initial treatment? That's the

e> heart of the University of Minnesota study. Within six months,

e> continuing topical metronidazole reduced the occurrence and severity

e> of relapse in about half of those who relapsed. But note that over

e> half of these moderate-severe patients not using prophylactic topical

e> metronidazole did not relapse during the study's 6 months; I'm not

e> aware of studies that look at chronic prophylatic topical

e> metronidazole beyond six months, but retreatment may be a preferred

e> option for patients who relapse less than twice a year.

e> You might discuss these results with your physician, to see if

e> continuing with once-daily Noritate for the full initial treatment

e> course of 12 weeks will provide for maximum improvement of your

e> symptoms beyond 30-40%. After initial therapy, it's not unreasonable

e> for your doctor to recommend tapering treatment to see how your skin

e> responds over time, eventually without any Noritate or using it just

e> as-needed, rather than committing you to once-daily treatment

e> indefinitely. As you say, the desert conditions may provide for

e> ongoing irritation to your rosacea. But if your skin is less inflamed

e> it may no longer be sensitive to these conditions.

e> You aren't my patient, and I'm an emergency physician not a

e> dermatologist, so please don't take anything I say as clinical advice

e> or treatment! That's not how the above information was intended at

e> all. I've had to educate myself on rosacea to help manage my own

e> symptoms, so the above is based on my understanding of the

e> literature, from my perspective. But I hope it helps. I thought your

e> questions were good ones.

e> Good luck.

e> Marjorie

e> Marjorie Lazoff, MD

e> Arch Dermatol 1998 Jun;134(6):679-83

e> Topical metronidazole maintains remissions of rosacea.

e> Dahl MV, Katz HI, Krueger GG, Millikan LE, Odom RB, F, Wolf JE

e> Jr, Aly R, Bayles C, Reusser B, Weidner M, E, Patrignelli R,

e> Tuley MR, Baker MO, Herndon JH Jr, Czernielewski JM.

e> Department of Dermatology, University of Minnesota, Minneapolis, USA.

e> BACKGROUND: cea is a chronic skin disease that requires long-term

e> therapy. Oral antibiotics and topical metronidazole successfully

e> treat rosacea. Because long-term use of systemic antibiotics carries

e> risks for systemic complications and adverse reactions, topical

e> treatments are preferred. OBJECTIVE: To determine if the use of

e> topical metronidazole gel (Metrogel) could prevent relapse of

e> moderate to severe rosacea. DESIGN: A combination of oral

e> tetracycline and topical metronidazole gel was used to treat 113

e> subjects with rosacea (open portion of the study). Successfully

e> treated subjects (n = 88) entered a randomized, double-blind, placebo-

e> controlled study applying either 0.75% topical metronidazole gel

e> (active agent) or topical metronidazole vehicle gel (placebo) twice

e> daily (blinded portion of the study). SETTING: Subjects were enrolled

e> at 6 separate sites in large cities at sites associated with major

e> medical centers. SUBJECTS: One hundred thirteen subjects with at

e> least 6 inflammatory papules and pustules, moderate to severe facial

e> erythema and telangiectasia entered the open phase of the study.

e> Eighty-eight subjects responded to treatment with systemic

e> tetracycline and topical metronidazole gel as measured by at least a

e> 70% reduction in the number of inflammatory lesions. These subjects

e> were randomized to receive 1 of 2 treatments: either 0.75%

e> metronidazole gel or placebo gel. INTERVENTIONS: Subjects were

e> evaluated monthly for up to 6 months to determine relapse rates. MAIN

e> OUTCOME MEASURES: Inflammatory papules and pustules were counted at

e> each visit. Relapse was determined by the appearance of a clinically

e> significant increase in the number of papules and pustules.

e> Prominence of telangiectases and dryness (roughness and scaling) were

e> also observed. RESULTS: In the open phase, treatment with

e> tetracycline and metronidazole gel eliminated all papules and

e> pustules in 67 subjects (59%). The faces of 104 subjects (92%)

e> displayed fewer papules and pustules after treatment, and 82 subjects

e> (73%) exhibited less erythema. In the randomized double-blind phase,

e> the use of topical metronidazole significantly prolonged the disease-

e> free interval and minimized recurrence compared with subjects treated

e> with the vehicle. Eighteen (42%) of 43 subjects applying the vehicle

e> experienced relapse, compared with 9 (23%) of 39 subjects applying

e> metronidazole gel (P<.05). The metronidazole group had fewer papules

e> and/or pustules after 6 months of treatment (P<.01). Relapse of

e> erythema also occurred less often in subjects treated with

e> metronidazole (74% vs 55%). CONCLUSION: In a majority of subjects

e> studied, continued treatment with metronidazole gel alone maintains

e> remission of moderate to severe rosacea induced by treatment with

e> oral tetracycline and topical metronidazole gel.

e> PMID: 9645635 [PubMed - indexed for MEDLINE]

e> --

e> Please read the list highlights before posting to the whole group

(http://rosacea.ii.net/toc.html). Your post will be delayed if you don't give a

meaningful subject or trim your reply text. You

e> must change the subject when replying to a digest !

e> See http://www.drnase.com for info on his recently published book.

e> To leave the list send an email to

rosacea-support-unsubscribe

e>

[Guest guest]

Metronidazole _is_ the most proven treatment for cea. Thanks to

Galderma it has been tested, promoted and disseminated at large.

For those who can tolerate it, there is a reasonable likelihood that it

will give a reasonable benefit. Further there has been some results that

show long term maintenance with these topicals is a viable option.

Sadly many of the list members do not fall into this category - and hence

hang around wanting more. Those with severe rosacea, with strong contact

allergies, and with a strong vascular/flushing component to their rosacea

will find the metronidazole stories hollow.

I myself found rozex to be a reasonable treatment, but in the end it was

quite expensive and I found another regime that suited me better.

BTW it is still unknown how it works, it is not a typical antibiotic. Also

there is some promise that specially formulated ocular formulations of

metronidazole will be useful for ocular rosacea sufferers. The current

formulations are definitely _not_ for ocular use - it specifically warns

against it in the patient insert.

cheers,

davidp.

--

Pascoe, mailto:dp@..., South Perth, Western Australia

e>

>> After six weeks of initial use, I am pleased to say that Noritate

>> has reduced the appearance of my rosacea by 30 to 40 percent. My

>> doctor said that I could try tapering off application of Noritate

>> from once a day to every so many days or just on the days that I

>> had flares. Has anyone using Noritate seen complete improvement?

>> Have you reduced your application of it from daily use?

e> A 1998 study from the University of Minnesota addresses your

e> concerns, albeit indirectly. This was a multi-center, randomized,

e> double-blind, placebo control study (the most rigorous study design

e> study in clinical research); although it only used one formulation of

e> topical metronidazole, other studies suggest its results can be

e> generalized to all formulations, including Noritate. I've pasted the

e> abstract below.

e> Regarding complete improvement: out of 113 patients with moderate-to-

e> severe rosacea, 88 (78%) responded with a signficant (70%) reduction

e> in inflammation and 67 (59%) had complete cessation of symptoms using

e> both oral antibiotics and topical metronidazole gel. (You didn't

e> mention taking oral antibiotics, although it's not clear whether

e> adding oral antibiotics to well-tolerated topical therapy adds much

e> in the long run). I don't recall the length of time these patients

e> were treated, although your time course of 6 weeks is on the short

e> side for initial treatment (usually 6-12 weeks). Finally, the study's

e> definition of moderate-to-severe rosacea may not match your clinical

e> condition.

e> A less academically rigorous study was published this past November

e> in the Journal of American Academy of Dermatology. Those researchers

e> found that out of 70 patients (requiring more severe rosacea for

e> entry than the above study), almost half had a " clear to mild

e> condition " after 12 weeks of just topical metronidazole treatment.

e> So, based on these studies, after an initial course of therapy with

e> antibiotics, topical with/without oral, about 75% had significant

e> improvement and about half had complete or near-complete reversal of

e> rosacea symptoms.

e> How many continue to do well after initial treatment? That's the

e> heart of the University of Minnesota study. Within six months,

e> continuing topical metronidazole reduced the occurrence and severity

e> of relapse in about half of those who relapsed. But note that over

e> half of these moderate-severe patients not using prophylactic topical

e> metronidazole did not relapse during the study's 6 months; I'm not

e> aware of studies that look at chronic prophylatic topical

e> metronidazole beyond six months, but retreatment may be a preferred

e> option for patients who relapse less than twice a year.

e> You might discuss these results with your physician, to see if

e> continuing with once-daily Noritate for the full initial treatment

e> course of 12 weeks will provide for maximum improvement of your

e> symptoms beyond 30-40%. After initial therapy, it's not unreasonable

e> for your doctor to recommend tapering treatment to see how your skin

e> responds over time, eventually without any Noritate or using it just

e> as-needed, rather than committing you to once-daily treatment

e> indefinitely. As you say, the desert conditions may provide for

e> ongoing irritation to your rosacea. But if your skin is less inflamed

e> it may no longer be sensitive to these conditions.

e> You aren't my patient, and I'm an emergency physician not a

e> dermatologist, so please don't take anything I say as clinical advice

e> or treatment! That's not how the above information was intended at

e> all. I've had to educate myself on rosacea to help manage my own

e> symptoms, so the above is based on my understanding of the

e> literature, from my perspective. But I hope it helps. I thought your

e> questions were good ones.

e> Good luck.

e> Marjorie

e> Marjorie Lazoff, MD

e> Arch Dermatol 1998 Jun;134(6):679-83

e> Topical metronidazole maintains remissions of rosacea.

e> Dahl MV, Katz HI, Krueger GG, Millikan LE, Odom RB, F, Wolf JE

e> Jr, Aly R, Bayles C, Reusser B, Weidner M, E, Patrignelli R,

e> Tuley MR, Baker MO, Herndon JH Jr, Czernielewski JM.

e> Department of Dermatology, University of Minnesota, Minneapolis, USA.

e> BACKGROUND: cea is a chronic skin disease that requires long-term

e> therapy. Oral antibiotics and topical metronidazole successfully

e> treat rosacea. Because long-term use of systemic antibiotics carries

e> risks for systemic complications and adverse reactions, topical

e> treatments are preferred. OBJECTIVE: To determine if the use of

e> topical metronidazole gel (Metrogel) could prevent relapse of

e> moderate to severe rosacea. DESIGN: A combination of oral

e> tetracycline and topical metronidazole gel was used to treat 113

e> subjects with rosacea (open portion of the study). Successfully

e> treated subjects (n = 88) entered a randomized, double-blind, placebo-

e> controlled study applying either 0.75% topical metronidazole gel

e> (active agent) or topical metronidazole vehicle gel (placebo) twice

e> daily (blinded portion of the study). SETTING: Subjects were enrolled

e> at 6 separate sites in large cities at sites associated with major

e> medical centers. SUBJECTS: One hundred thirteen subjects with at

e> least 6 inflammatory papules and pustules, moderate to severe facial

e> erythema and telangiectasia entered the open phase of the study.

e> Eighty-eight subjects responded to treatment with systemic

e> tetracycline and topical metronidazole gel as measured by at least a

e> 70% reduction in the number of inflammatory lesions. These subjects

e> were randomized to receive 1 of 2 treatments: either 0.75%

e> metronidazole gel or placebo gel. INTERVENTIONS: Subjects were

e> evaluated monthly for up to 6 months to determine relapse rates. MAIN

e> OUTCOME MEASURES: Inflammatory papules and pustules were counted at

e> each visit. Relapse was determined by the appearance of a clinically

e> significant increase in the number of papules and pustules.

e> Prominence of telangiectases and dryness (roughness and scaling) were

e> also observed. RESULTS: In the open phase, treatment with

e> tetracycline and metronidazole gel eliminated all papules and

e> pustules in 67 subjects (59%). The faces of 104 subjects (92%)

e> displayed fewer papules and pustules after treatment, and 82 subjects

e> (73%) exhibited less erythema. In the randomized double-blind phase,

e> the use of topical metronidazole significantly prolonged the disease-

e> free interval and minimized recurrence compared with subjects treated

e> with the vehicle. Eighteen (42%) of 43 subjects applying the vehicle

e> experienced relapse, compared with 9 (23%) of 39 subjects applying

e> metronidazole gel (P<.05). The metronidazole group had fewer papules

e> and/or pustules after 6 months of treatment (P<.01). Relapse of

e> erythema also occurred less often in subjects treated with

e> metronidazole (74% vs 55%). CONCLUSION: In a majority of subjects

e> studied, continued treatment with metronidazole gel alone maintains

e> remission of moderate to severe rosacea induced by treatment with

e> oral tetracycline and topical metronidazole gel.

e> PMID: 9645635 [PubMed - indexed for MEDLINE]

e> --

e> Please read the list highlights before posting to the whole group

(http://rosacea.ii.net/toc.html). Your post will be delayed if you don't give a

meaningful subject or trim your reply text. You

e> must change the subject when replying to a digest !

e> See http://www.drnase.com for info on his recently published book.

e> To leave the list send an email to

rosacea-support-unsubscribe

e>

[Guest guest]

> Metronidazole _is_ the most proven treatment for cea. Thanks to

> Galderma it has been tested, promoted and disseminated at large.

It's probably not a good idea for me to disagree with the list owner,

especially after he wrote such a nice post yesterday , but I would

argue that the most proven treatment for cea is oral doxycycline.

It's very safe and very effective, but it's a cheap generic product

so there's no brand name drug company promoting/marketing it.

Topical antibiotics are used alone for mild cases of rosacea only.

Their best role is in maintenance treatment, since they are

essentially side effect-free for those who can tolerate them. But

many rosaceans require oral doxycycline for maintenance treatment,

used at a fraction of the dose prescribed for initial treatment.

(Just to clarify, treatment of rosacea is divided into initial (when

first diagnosed, or for serious flares/breakouts) and maintenance

therapy (everyday use). Not everyone needs maintenance therapy, but

those who suffer from recurrent symptoms or frequent breakouts

probably do.)

I wouldn't thank Galderma since I don't believe they discovered the

link between antibiotics and rosacea. I suspect they're just taking

advantage of marketing opportunities, including funding pro-Galderma

research and other ways to favorably promote their product. That's

not to vilefy them, it's just reality.

(Again just to clarify, Galderma makes three topical metronidazole

products that differ only in inactive ingredients -- very important

to consider with skin sensitivities and type of skin: Metogel,

Metrolotion, and Metrocream. Another popular topical metronidazole,

made by another company, Noritate, is also a cream, but with

different inactive ingredients than Metrocream. It's a bit stronger

(1% instead of 0.75%) and is usually prescribed once instead of twice

a day. Aside from Noritate's popular formulation, once-daily use is

much easier and cheaper. Galderma is going after Noritate's market

share -- this fall they released a study they funded showing that

once-daily use of their products is just as effective as once-daily

Noritate.)

> Sadly many of the list members do not fall into this category - and

> hence hang around wanting more. Those with severe rosacea, with

> strong contact allergies, and with a strong vascular/flushing

> component to their rosacea will find the metronidazole stories

> hollow.

Not necessarily. Oral and/or topical antibiotics may well be

partially effective, especially if accompanied by good (simple) skin

care and atttention to major triggers and if given long enough time

(1-2 months may be necessary to see any effect). It is true that

antibiotics are less effective with vascular than with the

inflammatory components of rosacea, but still some red rosaceans find

them effective.

> I myself found rozex to be a reasonable treatment, but in the end

it was

> quite expensive and I found another regime that suited me better.

Rozex is another topical metronidazole, distributed outside the US by

Galderma; I don't believe it is available in the US. The formulation

is similiar to Noritate, but at 0.75% rather than 1% strength.

What are you using now, ?

> BTW it is still unknown how it works, it is not a typical

> antibiotic.

All the products above are typical antibiotics, . We don't know

exactly how antibiotics work in treating rosacea specifically, but

it's generally regarded to be as an anti-inflammatory agent, not by

killing bacteria (the primary, but not the only, use for antibiotics.)

That's why oral and topical antibiotics can take 3-6 weeks before any

improvement is noted, and 6-12 weeks for a full course effect. Many

rosaceans don't see any effect from oral or topical antibiotics until

after a full month. That's especially true if subtly irritating

cleansers and moisturizers and other ingredients counteract the anti-

inflammatory effect. It takes a long time to get the anti-

inflammatory action going.

Marjorie

Marjorie Lazoff, MD

[Guest guest]

> It's probably not a good idea for me to disagree with the list owner,

> especially after he wrote such a nice post yesterday , but I would

> argue that the most proven treatment for cea is oral doxycycline.

> It's very safe and very effective, but it's a cheap generic product

> so there's no brand name drug company promoting/marketing it.

But people with abdominal problems can't take oral antiobiotics, such as

myself.

[Guest guest]

> It's probably not a good idea for me to disagree with the list owner,

> especially after he wrote such a nice post yesterday , but I would

> argue that the most proven treatment for cea is oral doxycycline.

> It's very safe and very effective, but it's a cheap generic product

> so there's no brand name drug company promoting/marketing it.

But people with abdominal problems can't take oral antiobiotics, such as

myself.