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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

1116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-12

Study Completion Date

2018-09-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Azelaic acid foam 15%

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

Group Type ACTIVE_COMPARATOR

Azelaic acid foam 15%

Intervention Type DRUG

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).

Group Type ACTIVE_COMPARATOR

Finacea® (Azelaic acid Foam) 15%

Intervention Type DRUG

Azelaic acid foam 15%

Vehicle of the test product

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

Group Type PLACEBO_COMPARATOR

Vehicle of the test product

Intervention Type DRUG

Vehicle of the test product

Interventions

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Azelaic acid foam 15%

Intervention Type DRUG

Finacea® (Azelaic acid Foam) 15%

Azelaic acid foam 15%

Intervention Type DRUG

Vehicle of the test product

Intervention Type DRUG

Other Intervention Names

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AZAF 1703 Placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes