To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Azeliac Acid Gel and Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea.

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: Azelaic Acid 15% topical gel; Drug: Finacea® (azelaic acid) Gel, 15%; Drug: Placebo

Detailed Description

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, comparing AZELAIC ACID TOPICAL GEL 15% TO FINACEA® and both active treatments to a Placebo Control in the treatment of Moderate of Facial Rosacea.

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male or non-pregnant female ≥ 18 years-of-age with a clinical diagnosis of moderate facial rosacea;
• Subjects had to have a definite clinical diagnosis of facial rosacea severity Grade 3 as per the IGE

Exclusion Criteria:

• Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Azelaic Acid 15% topical gel; Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face	Drug: Azelaic Acid 15% topical gel; Gel; Other Names: Azelaic Acid
Active Comparator: Finacea® (azelaic acid) Gel, 15%; Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face	Drug: Finacea® (azelaic acid) Gel, 15%; Gel; Other Names: Azelaic Acid
Placebo Comparator: Placebo; Topically to the face, twice a day A thin layer of study treatment was gently massaged into the affected areas on the face	Drug: Placebo; Gel; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inflammatory lesion counts	Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts	12 weeks

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA
• Investigators: Study Chair: Catawba Research, http://catawbaresearch.com/contact/

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Antineoplastic Agents; Dermatologic Agents; Azelaic acid
• Other Study ID Numbers: AZAG 1533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes