Back to resultsTo Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel
Primary Purpose
Rosacea
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Azelaic Acid 15% topical gel
Finacea® (azelaic acid) Gel, 15%
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea
Eligibility 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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Azelaic Acid 15% topical gel
Finacea® (azelaic acid) Gel, 15%
Placebo
Arm Description
Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face
Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face
Topically to the face, twice a day A thin layer of study treatment was gently massaged into the affected areas on the face
Outcomes
Primary Outcome Measures
Change in inflammatory lesion counts
Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03094403
Brief Title
To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
April 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azelaic Acid 15% topical gel
Arm Type
Experimental
Arm Description
Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face
Arm Title
Finacea® (azelaic acid) Gel, 15%
Arm Type
Active Comparator
Arm Description
Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Topically to the face, twice a day A thin layer of study treatment was gently massaged into the affected areas on the face
Intervention Type
Drug
Intervention Name(s)
Azelaic Acid 15% topical gel
Other Intervention Name(s)
Azelaic Acid
Intervention Description
Gel
Intervention Type
Drug
Intervention Name(s)
Finacea® (azelaic acid) Gel, 15%
Other Intervention Name(s)
Azelaic Acid
Intervention Description
Gel
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle
Intervention Description
Gel
Primary Outcome Measure Information:
Title
Change in inflammatory lesion counts
Description
Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catawba Research
Organizational Affiliation
http://catawbaresearch.com/contact/
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel
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