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

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Rosacea

Treatments: Drug: Azelaic acid foam 15%; Drug: Finacea® (Azelaic acid Foam) 15%; Drug: Vehicle of the test product

Study type: Interventional

Funder types: Industry

Identifiers

NCT03689010

AZAF-1703

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,116 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,116 participants in 3 patient groups, including a placebo group

Azelaic acid foam 15%

Active Comparator group

Description:

Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose).

Treatment:

Drug: Azelaic acid foam 15%

Finacea® (azelaic acid) Foam, 15%

Active Comparator group

Description:

Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose).

Treatment:

Drug: Finacea® (Azelaic acid Foam) 15%

Vehicle of the test product

Placebo Comparator group

Description:

Topical, twice daily (Apply the foam (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose).

Treatment:

Drug: Vehicle of the test product