Treatment of rosacea with 1% metronidazole cream. A double-blind study

Nielsen, P. Gamborg

doi:10.1111/j.1365-2133.1983.tb03972.x

Cited by 86 publications

(51 citation statements)

References 7 publications

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“…Since no change occurred in telangiectasia and rhinophyma, we thought that permethrin 5% cream and metronidazole 0.75% gel had no effect on telangiectasia and rhinophyma and, therefore, did not make any statistical analysis of telangiectasia and rhinophyma scores. Our finding that metronidazole 0.75% gel did not have any effect on telangiectasia and rhinophyma was consistent with the results of previous studies [4, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29]. …”

Section: Discussionsupporting

confidence: 83%

Permethrin 5% Cream versus Metronidazole 0.75% Gel for the Treatment of Papulopustular Rosacea

et al. 2002

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Background: Permethrin 5% cream used against human ectoparasites suggests that it may be effective in papulopustular rosacea. Methods: This study included 63 patients diagnosed as having papulopustular rosacea based on the clinical and histological findings. Patients were randomly assigned into permethrin (n = 23), metronidazole (n = 20) and placebo (n = 20) groups. Scores of erythema, telangiectasia, edema and rhinophyma and the numbers of papules, pustules, inflammatory nodules and Demodex folliculorum were determined. Twenty-three patients were given permethrin 5% cream (Zalvor 5% skin cream^®), 20 patients metronidazole 0.75% gel (Roza gel^®) and 20 patients placebo cream (Basis cream^®), in packages looking identical to those of metronidazole and permethrin creams, and were recommended to apply them to their faces twice a day. All patients were also given SPF 20 cream for protection against sunlight. Two months of treatment were planned, and the patients were invited to the clinic for fortnightly controls. Scores of erythema, telangiectasia, edema and rhinophyma and the numbers of papules, pustules, inflammatory nodules and D. folliculorum were recorded at each visit. The mean scores of erythema and the mean numbers of papules, pustules and D. folliculorum were determined at baseline and on days 15, 30, 45 and 60. Side effects were also detected. Results: The effect of permethrin 5% cream on D. folliculorum was superior to that of metronidazole 0.75% gel. The effect of permethrin 5% cream on erythema and papules was found to be more effective than placebo and as effective as metronidazole 0.75% gel. However, it had no effect on telangiectasia, rhinophyma and pustules. Conclusion: It can be concluded that the application of permethrin 5% cream twice daily for 2 months can be as effective and reliable as metronidazole in the treatment of rosacea and a greater benefit can be gained when it is combined with other systemic and/or topical treatments.

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Section: Discussionsupporting

confidence: 83%

Permethrin 5% Cream versus Metronidazole 0.75% Gel for the Treatment of Papulopustular Rosacea

et al. 2002

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“…Orally it is as effec tive as oxytetracycline in the treatment of papulopustular rosacea, a common inflamma tory skin disease affecting the face [1]. It is also effective topically in a cream formulation [2], More recently the use of metronidazole in an aqueous gel vehicle has been described [3,4] and this seems to be a superior vehicle as fewer side-effects were noted. In the UK, met ronidazole is currently available as a 0.75% formulation in a water-based gel (Metrogel®, Sandoz Pharmaceuticals).…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics of Topically Applied Metronidazole in Two Different Formulations

Dykes

Hill

Marks³

1997

Skin Pharmacol Physiol

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Topical metronidazole is effective in the treatment of papulo-pustular rosacea, a common inflammatory disease of the face. In this study, a comparison of the bio-availability of two topical formulations (A and B) of 0.75% metronidazole has been made. Twenty-four subjects took part in a double-blind study where each was randomly allocated to four groups corresponding to 0.5, 1, 2 and 4 h of treatment. A single application was made to each forearm and after increasing times of contact, samples of stratum corneum were removed by the skin surface biopsy (SSB) technique. After SBB removal, a full-thickness skin biopsy was taken. The tissues were extracted and analysed by an HPLC method. Both formulations showed rapid percutaneous penetration. Formulation A gave the highest concentrations at the lowest levels of the stratum corneum at 4 h. Thus in SSB5, the mean drug concentrations at 4 h were as follows: A, 6.20 ± 1.16 μg cm^-2; B, 1.93 ± 0.98 μg cm-². A similar difference was observed when the levels in the punch biopsies were determined. At 4 h, the mean drug levels were: A, 6.07 ± 2.17 μgmg^-1; B, 0.95 ± 1.16 μgmg^-1. Formulation A clearly gives a higher rate of percutaneous penetration leading to higher tissue levels of drug. Whether this increase leads to a clinically more effective treatment has yet to be determined.

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“…Forty-two studies were included in this quality assessment evaluating the treatment of rosacea [1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42]. The study design of these papers included 29 double-blind, 1 single-blind, and 9 open-labeled reports.…”

Section: Resultsmentioning

confidence: 99%

Evaluating the Quality of Rosacea Studies: Implications for the Patient and Physician

Gupta

Chaudhry

2003

Dermatology

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Background: Patients suffering from rosacea may experience frequent blushing and flushing, erythema, telangiectasia, and/or rhinophyma. In an attempt to find effective treatments, many studies have been performed. Objective: It is important to be able to evaluate the quality of clinical trials where agents have been used to treat rosacea, and to compare the effectiveness of the different therapies used for this indication. Methods: The reports on the efficacy and safety of the different drug therapies were evaluated using predetermined criteria. We searched MEDLINE (1966–2002) for studies where rosacea was treated with the various therapies. The criteria used to assess the quality of the studies were: randomization, blinding (double, single, or open), aims clearly defined, prior sample size calculation, whether inclusion and/or exclusion criteria were outlined, baseline comparison of patient characteristics and demographics, interventions and efficacy parameters defined, compliance assessed, statistical analysis performed including intention-to-treat evaluation of efficacy of therapy. Results: Using the above-mentioned criteria, each study was rated in order to determine the quality of the clinical trial. The maximum score a study could attain was 20. To determine if high-quality studies are cited more often than the lower-quality papers, the number of times a study had been cited since its publication was measured. We found 13 of the 42 studies scored greater than 14; these studies were rated as high-quality studies. There was no significant association between high-quality papers and the number of times they had been cited, suggesting that other factors are also taken into consideration when a given study is cited. Conclusion: It is important for investigators and clinicians to be aware of the parameters that count towards designing a high-quality protocol since such studies are more likely to reflect efficacy rates that are accurate. Furthermore, it is essential that when a study is written up, the pertinent information regarding the design of the trial and the manner in which it was conducted are conveyed to the reader.

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Treatment of rosacea with 1% metronidazole cream. A double-blind study

Cited by 86 publications

References 7 publications

Permethrin 5% Cream versus Metronidazole 0.75% Gel for the Treatment of Papulopustular Rosacea

Permethrin 5% Cream versus Metronidazole 0.75% Gel for the Treatment of Papulopustular Rosacea

Pharmacokinetics of Topically Applied Metronidazole in Two Different Formulations

Evaluating the Quality of Rosacea Studies: Implications for the Patient and Physician

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