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1.
Cutis ; 98(3): 187-194, 2016 Sep.
Article in English | MEDLINE | ID: mdl-27814413

ABSTRACT

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.


Subject(s)
Dicarboxylic Acids/administration & dosage , Rosacea , Administration, Cutaneous , Dermatologic Agents/administration & dosage , Dosage Forms , Double-Blind Method , Female , Humans , Male , Rosacea/drug therapy , Rosacea/pathology , Severity of Illness Index , Symptom Assessment/methods , Treatment Outcome
2.
Cutis ; 96(1): 54-61, 2015 Jul.
Article in English | MEDLINE | ID: mdl-26244354

ABSTRACT

Rosacea is a chronic relapsing skin disorder primarily affecting the face. Although its etiology is not well defined, rosacea is associated with immune dysregulation and inflammation potentiated by external factors. These manifestations lead to skin sensitivity and impaired quality of life. Azelaic acid (AzA) is approved for the treatment of rosacea in a 15% gel formulation. This phase 3 study evaluated the efficacy and safety of AzA in a 15% foam formulation for the treatment of papulopustular rosacea (PPR). Coprimary efficacy end points were treatment success according to investigator global assessment (IGA) and the nominal change in inflammatory lesion count (ILC) from baseline to the end of treatment (EoT). Adverse events (AEs) were evaluated as a measure of safety. The IGA success rate at EoT was significantly greater in the AzA foam group versus vehicle (P<.001; Cochran-Mantel-Haenszel test). Likewise, nominal ILC change at EoT in the AzA foam group showed a significantly greater decrease versus vehicle (P<.001; F test). Drug-related AEs were mainly mild to moderate, cutaneous, and local. Overall, the study results support the efficacy and safety of twice-daily AzA foam 15% in patients with PPR.


Subject(s)
Dermatologic Agents/therapeutic use , Dicarboxylic Acids/therapeutic use , Quality of Life , Rosacea/drug therapy , Administration, Cutaneous , Adult , Aged , Chronic Disease , Dermatologic Agents/administration & dosage , Dermatologic Agents/adverse effects , Dicarboxylic Acids/administration & dosage , Dicarboxylic Acids/adverse effects , Double-Blind Method , Female , Follow-Up Studies , Humans , Male , Middle Aged , Severity of Illness Index , Treatment Outcome
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