A Double-Blind Randomised Study of Metronidazole (Flagyl®) 1% Cream in the Treatment of Acne Rosacea

Abstract

A double-blind. placebo-controlled study was conducted with 100 adult patients presenting with acne rosacea. 50 patients were randomly assigned to treatment with metronidazole I % cream, while the other 50 patients received placebo cream. The cream was applied morning and evening in a dose of 0.25 cm 2 per application. Clinical assessments were performed prior to drug administration and after I and 2 months of treatment.The number and severity of rosacea lesions (papules and pustules) were significantly reduced with both treatments during the first month, but the response was significantly greater with metronidazole I % cream (p < 0.05). During the second month. lesion counts continued to decline with metronidazole I % cream. but remained the same or worsened with placebo. Metronidazole was significantly better than placebo (p < 0.05).Lesions occurring at all facial sites (forehead. cheeks. chin, nose) responded to metronidazole cream. The most dramatic effect occurred on the forehead. where lesions were eradicated in II of 19 patients (58%). At other sites, metronidazole eradicated lesions in approximately 25% of the patients versus approximately 10% with placebo.Other symptoms of acne rosacea, such as erythema, erythrosis and telangiectasiae improved slightly, but there were no significant differences between treatments. Metronidazole 1% cream was well tolerated throughout the study, with no serious adverse effects or laboratory abnormalities.Acne rosacea is a chronic skin condition affecting primarily the central part of the face causing severe erythema, papules, pustules and telangiectasiae. Rhynophyma, seen more often in men than women, consists of sebaceous hyperplasia of the nose and is usually seen in severe cases. Occasionally, blepharitis and conjunctivitis will accompany facial lesions. Although the condition is thought to be an inflammatory response, the pathogenesis is not fully understood. Some clinicians have linked the condition to an increase in the population of the skin mite, Demodex folliculorum, particularly in hyperseborrhoeic individuals. Rosacea has also been attributed to vitamin deficiencies, endocrine

Randomized Placebo-controlled Trial of Metronidazole 1% Cream with Sunscreen SPF 15 in Treatment of Rosacea

“…8,10 The reduction in erythema score of 41% from baseline in the present study is also within the range observed in previous investigations: 35% 6 -90%. 10 While the 12-week duration of the current study is longer than that of previous studies, significant improvement in inflammatory lesion count and erythema was first noted at week 4 (first observation visit) and week 8 for these parameters, respectively.…”

“…[6][7][8][9][10] The 65% reduction in total inflammatory lesions (papules and pustules) from baseline counts observed in the present study …”

“…Improvement in telangiectasiae had not been previously observed in other placebo-controlled studies of topical metronidazole which used similar severity scales. 7,8 In these trials, sunscreens were not a component of active or placebo treatment, unlike the present study. Inadequate detail regarding severity of telangiectasiae at baseline and during treatment in previous studies confounds comparison and analysis.…”

Rosacea: II. Therapy

“…Many double-blind, placebo-controlled trials of topical metronidazole have demonstrated beneficial effects in the treatment of rosacea. [10][11][12][14][15][16][17][18][19][20] Breneman et al compared the efficacy of once-daily metronidazole 1% cream with that of the vehicle alone in 139 patients. Significant reductions in inflammatory lesions were reached at 4 weeks.…”

Measurement of the severity of rosacea

“…4,5 Color scales were used to assess the degree of erythema by several authors. [6][7][8] Several authors used specialized equipment to assess skin changes, especially in regard to the degree of erythema and color change in rosacea, [9][10][11] and one author examined histologic changes in affected skin. 12 While some of these methods may have improved the internal validity of the observations made in these studies, none of these techniques were described or validated well enough to promote their general use in other studies.…”