To Evaluate the Therapeutic Equivalence and Safety in Treatment of Moderate Facial Rosacea

Phase 1

Completed

• Conditions: Rosacea
• Interventions: Drug: Finacea® (Azelaic acid Foam) 15%; Drug: Azelaic acid foam 15%; Drug: Vehicle of the test product

• Registration Number: NCT03689010
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate facial rosacea.

Detailed Description

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study, comparing test and reference products and both active treatments to a placebo control in the treatment of Moderate Facial Rosacea.

Study Timeline

• Study Start: 2017-12-12
• Primary Completion: 2018-08-09
• Study First Submitted: 2018-09-21
• Study First Submitted QC: 2018-09-26
• Study Completion: 2018-09-28
• Study First Posted: 2018-09-28
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-15
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1116

Inclusion Criteria

• Healthy male or non-pregnant female aged ≥ 18 with a clinical diagnosis of facial rosacea.
• Subjects must have provided IRB approved written informed consent.

Exclusion Criteria

• Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
• Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Finacea® (azelaic acid) Foam, 15%	Finacea® (Azelaic acid Foam) 15%	Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose).
Azelaic acid foam 15%	Azelaic acid foam 15%	Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose).
Vehicle of the test product	Vehicle of the test product	Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose).

Primary Outcome Measures

Name	Time	Method
change in the inflammatory lesion counts	12 weeks	Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts

Trial Locations

Locations (1)

Catawba Research, LLC; 🇺🇸 Charlotte, North Carolina, United States