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

NCT03094403 | Completed Phase 1 FDA Drug

• 1 other identifier: AZAG 1533
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

• Change in inflammatory lesion counts

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

  12 weeks

Study Arms (3)

Azelaic Acid 15% topical gel

EXPERIMENTAL

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

Finacea® (azelaic acid) Gel, 15%

ACTIVE COMPARATOR

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%

Placebo

PLACEBO COMPARATOR

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

Interventions

Azelaic Acid 15% topical gel DRUG

Gel

Also known as: Azelaic Acid

Azelaic Acid 15% topical gel

Finacea® (azelaic acid) Gel, 15% DRUG

Gel

Also known as: Azelaic Acid

Finacea® (azelaic acid) Gel, 15%

Placebo DRUG

Gel

Also known as: Vehicle

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

MeSH Terms

Conditions

Rosacea

Interventions

azelaic acid; Gels

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Catawba Research

  http://catawbaresearch.com/contact/

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects in this randomized, double-blind, placebo controlled, parallel-group, multiple-center study will be randomly assigned in a 2:2:1 ratio to treatment with the test product, reference product or placebo control, respectively

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 29, 2017
• Study Start: July 1, 2016
• Primary Completion: March 31, 2017
• Study Completion: April 1, 2017
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share