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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03094403

Enrollment

1000

Registered

2017-03-29

Start date

2016-07-01

Completion date

2017-04-01

Last updated

2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rosacea

Brief summary

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

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.

Interventions

DRUGAzelaic Acid 15% topical gel

Gel

DRUGFinacea® (azelaic acid) Gel, 15%

Gel

DRUGPlacebo

Gel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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;

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026