Investigator-reported efficacy of azelaic acid foam 15% in patients with papulopustular rosacea: secondary efficacy outcomes from a randomized, controlled, double-blind, phase 3 trial.
Papulopustular rosacea (PPR) is characterized by centrofacial papules and pustules commonly associated with erythema. To compare investigator-reported efficacy outcomes for azelaic acid (AzA) foam 15% versus vehicle foam in PPR, a randomized, vehicle-controlled, double-blind phase 3 clinical trial was conducted at 48 US sites. Participants received AzA foam or vehicle foam for 12 weeks. Secondary efficacy outcomes included change in inflammatory lesion count (ILC), therapeutic response rate according to investigator global assessment (IGA), and change in erythema rating. This study was comprised of 961 participants with PPR. The results support the therapeutic superiority of AzA foam over vehicle foam.
Ameriderm Research, Ormond Beach, Florida, USA.
James A
JA
Solomon
Department of Dermatology, University of Texas Health Science Center, Houston, USA.
Stephen
S
Tyring
Bayer Pharmaceuticals, Berlin, Germany.
Gerald
G
Staedtler
Bayer Pharmaceuticals, Berlin, Germany.
Meike
M
Sand
Bayer Pharmaceuticals, Berlin, Germany.
Richard
R
Nkulikiyinka
Bayer Pharmaceuticals, Berlin, Germany.
Kaweh
K
Shakery
D000279:Administration, Cutaneous; D003879:Dermatologic Agents / Q000008:administration & dosage; D003998:Dicarboxylic Acids / Q000008:administration & dosage*; D004304:Dosage Forms; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D012393:Rosacea / Q000188:drug therapy / Q000473:pathology; D012720:Severity of Illness Index; D063189:Symptom Assessment / Q000379:methods; D016896:Treatment Outcome
D003879:Dermatologic Agents; D003998:Dicarboxylic Acids; D004304:Dosage Forms; C010038:azelaic acid