The benefit of a formulation of azelaic acid 15% and a complex of active ingredients for the treatment of papulopustular rosacea

INTERVENTION: This study is a 12‐week, double‐blind, vehicle‐controlled, parallel‐assigned‐group, randomized clinical trial performed in one centre in Colombia enrolling subjects with papulopustular rosacea randomly assigned to one of three intervention groups: the tested AZ cream (AZ group, n=24), metronidazole 0.75% cream (MZ group, n=23), or a vehicle cream (placebo group, n=22). The randomization was performed using Excel by the sponsor, via an excel formula of random distribution in 3 columns in a homogeneous way. The blank tubes were then delivered to the investigators already coded. Disclosure of the assignment was performed at the end of the study. Each subject had an envelope with his or her treatment amount for the 3 months. All the subjects were instructed to apply the products twice daily in the morning and evening on the face from baseline for a period of 12 weeks and as recommended by the manufacturer. Follow‐up visits were performed at baseline, and weeks 4, 8, and 12. CONDITION: Papulopustular rosacea phenotype ; Skin and Connective Tissue Diseases PRIMARY OUTCOME: Outcomes assessed at each study visit at baseline, and weeks 4, 8 and 12:; 1. Number of inflammatory papules and pustules on the forehead, nose, both left and right cheek and chin counted by the investigator and recorded in the study records ; 2. Investigator global assessment (IGA) score measured using a 7‐point static scoring system: (0: clear; 1: minimal; 2: mild; 3: mild to moderate; 4: moderate; 5: moderate to severe; 6: severe). ; 3. Global improvement in erythema severity measured using the Clinical Erythema Severity Score (ESS) on a 3‐point scale ranging from 0: mild to 2:?severe; 4. Incidence of adverse events (AEs) reported by the investigator and recorded in the study records ; 5. Cutaneous tolerability for the following clinical signs: burning, itching, and dryness measured using a 4‐point scale (0: none to 3: severe) SECONDARY OUTCOME: Improvement in signs and symptoms of papulopustular rosacea phenotype measured using a self‐assessment questionnaire with a 5‐point scale (0: worse; 1: unchanged; 2: mild improvement; 3: moderate improvement; 4: great improvement) at week 12 INCLUSION CRITERIA: 1. Male or female subjects aged 18 years and older 2. Clinical diagnosis of papulopustular rosacea (PPR) phenotype with at least 10 inflammatory lesions