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

Sponsor
Taro Pharmaceuticals USA (Industry)
Overall Status
Completed
CT.gov ID
NCT03689010
Collaborator
(none)
1,116
Enrollment
1
Location
3
Arms
9.5
Actual Duration (Months)
117.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Azelaic acid foam 15%
  • Drug: Finacea® (Azelaic acid Foam) 15%
  • Drug: Vehicle of the test product
 Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1116 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Taro Product to RLD, and Both Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea
Actual Study Start Date :
Dec 12, 2017
Actual Primary Completion Date :
Aug 9, 2018
Actual Study Completion Date :
Sep 28, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Azelaic acid foam 15%

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

Drug: Azelaic acid foam 15%
Azelaic acid foam 15%
Other Names:
  • AZAF 1703

    		•
    Active Comparator: Finacea® (azelaic acid) Foam, 15%

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

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

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

    Drug: Vehicle of the test product
    Vehicle of the test product
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change in the inflammatory lesion counts [12 weeks]

      Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Catawba Research, LLC Charlotte North Carolina United States 28217

    Sponsors and Collaborators

    • Taro Pharmaceuticals USA

    Investigators

    • Study Director: Natalie Yantovskiy, Taro Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Taro Pharmaceuticals USA
    ClinicalTrials.gov Identifier:
    NCT03689010
    Other Study ID Numbers:
    • AZAF-1703
    First Posted:
    Sep 28, 2018
    Last Update Posted:
    Mar 19, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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.:
    No
    Additional relevant MeSH terms:
    Rosacea
    Azelaic acid

    Study Results

    No Results Posted as of Mar 19, 2019