[Azelaic acid 15% gel in the treatment of acne vulgaris. Combined results of two double-blind clinical comparative studies].
BACKGROUND
Topical measures are still the mainstay in the therapy of mild-to-moderate acne vulgaris. Azelaic acid 20% in a cream formulation has been established as an efficacious and safe topical drug for 15 years. A new non-alcoholic hydrogel formulation containing 15% azelaic acid was clinically tested against two standard drugs--5% benzoyl peroxide (BPO) and 1% clindamycin.


METHODS
In two independent, randomized, blinded comparative trials 15% azelaic acid gel was clinically tested against 5% benzoyl peroxide (BPO) gel in 351 patients and against 1% clindamycin gel in 229 patients. The drugs were applied b.i.d. for 4 months.


RESULTS
Azelaic acid 15% gel proved to be as effective as BPO and clindamycin with median % reduction of the inflamed lesion (papules and pustules) of 70%, and 71% respectively. The azelaic acid gel was well-tolerated, the side effects (local burning and irritation) were distinctly less than with BPO but more pronounced than with clindamycin. Despite these side effects, the treatment was well-accepted by the majority of patients.


CONCLUSIONS
Azelaic acid gel is an effective topical monotherapy for mild-to-moderate acne vulgaris; its new gel form is an enrichment of acne therapy.
Gollnick
Harald P M
HP
Univ.-Hautklinik Magdeburg. harald.gollnick@medizin.uni-magdeburg.de
Graupe
Klaus
K
Zaumseil
Rolf-Peter
RP
D000152:Acne Vulgaris / Q000175:diagnosis* / Q000188:drug therapy*; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D001585:Benzoyl Peroxide / Q000008:administration & dosage*; D002648:Child; D002981:Clindamycin / Q000008:administration & dosage*; D003879:Dermatologic Agents / Q000008:administration & dosage*; D003998:Dicarboxylic Acids / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005782:Gels / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D003879:Dermatologic Agents; D003998:Dicarboxylic Acids; D005782:Gels; D002981:Clindamycin; C010038:azelaic acid; D001585:Benzoyl Peroxide