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

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Rosacea

Treatments: Drug: Placebo; Drug: Finacea® (azelaic acid) Gel, 15%; Drug: Azelaic Acid 15% topical gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03094403

AZAG 1533

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 3 patient groups, including a placebo group

Azelaic Acid 15% topical gel

Experimental group

Description:

Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face

Treatment:

Drug: Azelaic Acid 15% topical gel

Finacea® (azelaic acid) Gel, 15%

Active Comparator group

Description:

Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face

Treatment:

Drug: Finacea® (azelaic acid) Gel, 15%

Placebo

Placebo Comparator group

Description:

Topically to the face, twice a day A thin layer of study treatment was gently massaged into the affected areas on the face

Treatment:

Drug: Placebo