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

Abstract

French

Background:

Rosacea is a photoaggravated dermatosis responsive to treatment with topical and oral antibiotics. A formulation combining metronidazole 1% cream with sunscreen SPF 15 was developed for the treatment of rosacea. Objective: The objective of this study was to determine the safety and efficacy of a formulation combining metronidazole 1% cream with sunscreen SPF 15 in the treatment of moderate to severe rosacea.

Methods:

One hundred and twenty patients with moderate to severe rosacea were enrolled for a randomized, placebo-controlled (vehicle containing sunscreen with SPF 15), double-blind study. Study cream was applied twice daily to the entire face over a 12-week period.

Results:

Treatment with metronidazole 1% cream with sunscreen SPF 15 resulted in significant improvement (p < 0.05) in inflammatory lesion count, erythema and telangiectasiae scores, and investigator and patient global assessment scores compared with baseline and placebo. Adverse reactions related to study medication were typically mild, occurred at the site of application, and were reversible. There was no difference between the safety profiles of metronidazole 1% cream with sunscreen SPF 15 and placebo.

Conclusions:

The combined topical formulation of metronidazole 1% cream with sunscreen SPF 15 was an effective, well-tolerated topical agent for the treatment of moderate to severe rosacea.

Get full access to this article

View all access options for this article.

References

Greaves

, (1998) Flushing and flushing syndromes, rosacea and perioral dermatitis. In: Champion

Burton

. eds. Rook, Wilkinson, Ebling Textbook of Dermatology, 6th ed. Blackwell Scientific, Oxford Chap 46 pp 2105.

Shear

Levine

, Needs survey of Canadian rosacea patients. J Cutan Med Surg 1999; 3:178–181.

Plewig

Kligman

, (1993) Acne and rosacea. Springer-Verlag, Berlin pp 433, 439.

Nichols

Desai

Lebwohl

. Effective sunscreen ingredients and cutaneous irritation in patients with rosacea. Cutis 1998; 61:344–346.

McClellan

Noble

. Topical metronidazole: A review of its use in rosacea. Am J Clin Dermatol 2000; 1(3):191–199.

Nielsen

P Gamborg

. Treatment of rosacea with 1% metronidazole cream. A double-blind study. Br J Dermatol 1983; 108:327–332.

Bjerke

Nyfors

Austad

. Metronidazole (Elyzol) 1% cream v. placebo cream in the treatment of rosacea. Clin Trials J 1989; 26:187–194.

Bitar

Bourgouin

Dore

. A double-blind randomized study of Metronidazole (Flagyl®) 1 % cream in the treatment of acne rosacea. Drug Invest 1990; 2:242–248.

Jorizzo

Lebwohl

Tobey

. The efficacy of metronidazole 1% cream daily compared with metronidazole 1% cream twice daily and their vehicles in rosacea: A double-blind clinical trial. J Am Acad Dermatol 1998; 39:502–504.

10.

Breneman

Stewart

Hevia

. A double-blind, multicenter clinical trial comparing efficacy of once-daily metronidazole 1% cream to vehicle in patients with rosacea. Cutis 1998; 61:44–47.

11.

Msika

Choulot

Courty

. (2001) Novel formulation combining both genistein and a matrix metalloprotease inhibitor for rosacea treatment. Poster presented at the 59th Annual Meeting of American Academy of Dermatology, Washington, DC.

12.

Licu

Vie

Saint-Martory

. (2001) Efficacy and safety of a topical formulation with retinaldehyde on rosacea. Poster presented at the Annual Meeting of American Academy of Dermatology, Washington, DC.