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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03094403
Recruitment Status : Completed
First Posted : March 29, 2017
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

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

Condition or disease Intervention/treatment Phase
Rosacea Drug: Azelaic Acid 15% topical gel Drug: Finacea® (azelaic acid) Gel, 15% Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : April 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: Azelaic Acid 15% topical gel
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
Gel
Other Name: Azelaic Acid

Active Comparator: Finacea® (azelaic acid) Gel, 15%
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%
Gel
Other Name: Azelaic Acid

Placebo Comparator: Placebo
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
Gel
Other Name: Vehicle




Primary Outcome Measures :
  1. Change in inflammatory lesion counts [ Time Frame: 12 weeks ]
    Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094403


Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Chair: Catawba Research http://catawbaresearch.com/contact/

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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT03094403     History of Changes
Other Study ID Numbers: AZAG 1533
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Rosacea
Skin Diseases
Azelaic acid
Antineoplastic Agents
Dermatologic Agents