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

Primary Purpose

Rosacea

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Azelaic acid foam 15%

Finacea® (Azelaic acid Foam) 15%

Vehicle of the test product

About this trial

This is an interventional treatment trial for Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Catawba Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Azelaic acid foam 15%

Finacea® (azelaic acid) Foam, 15%

Vehicle of the test product

Arm Description

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

Outcomes

Primary Outcome Measures

change in the inflammatory lesion counts

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03689010

First Posted

September 21, 2018

Last Updated

March 15, 2019

Sponsor

Taro Pharmaceuticals USA

1. Study Identification

Unique Protocol Identification Number

NCT03689010

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

December 12, 2017 (Actual)

Primary Completion Date

August 9, 2018 (Actual)

Study Completion Date

September 28, 2018 (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

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

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

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Azelaic acid foam 15%

Arm Type

Active Comparator

Arm Description

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

Arm Title

Finacea® (azelaic acid) Foam, 15%

Arm Type

Active Comparator

Arm Description

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

Arm Title

Vehicle of the test product

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Azelaic acid foam 15%

Other Intervention Name(s)

AZAF 1703

Intervention Description

Azelaic acid foam 15%

Intervention Type

Drug

Intervention Name(s)

Finacea® (Azelaic acid Foam) 15%

Intervention Description

Azelaic acid foam 15%

Intervention Type

Drug

Intervention Name(s)

Vehicle of the test product

Other Intervention Name(s)

Placebo

Intervention Description

Vehicle of the test product

Primary Outcome Measure Information:

Title

change in the 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

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Natalie Yantovskiy

Organizational Affiliation

Taro Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Catawba Research, LLC

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28217

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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