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A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Trifarotene Cream 0.005%
Placebo
AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories)
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects ages 12 to 17 years of age inclusive must have provided IRB approved written assent; Subjects must have a definite clinical diagnosis of acne vulgaris of severity grade 2, 3,or 4 as per the Investigator's Global Assessment (IGA) Subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face. Exclusion Criteria: Female Subjects who are pregnant, nursing or planning to become pregnant during study participation Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients. Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis,squamous cell carcinoma, eczema, acneiform eruptions caused by medications,steroid acne, steroid folliculitis, or bacterial folliculitis).

Sites / Locations

  • Taro Pharmaceuticals USA Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Trifarotene Cream 0.005%

AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories)

Placebo Control

Arm Description

The study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days.

The study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days.

The study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days.

Outcomes

Primary Outcome Measures

Demonstration in Therapeutic Equivalence & Safety of the Investigational Product
Percent change in the inflammatory (papules and pustules) & non-inflammatory (open and closed comedones) lesion counts

Secondary Outcome Measures

Full Information

First Posted
September 20, 2023
Last Updated
September 27, 2023
Sponsor
Taro Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT06063473
Brief Title
A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris
Official Title
A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) and to AKLIEF® Cream (Trifarotene 0.005%,Galderma) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
July 13, 2023 (Actual)
Study Completion Date
July 13, 2023 (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
To demonstrate therapeutic equivalence and safety of Trifarotene cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and AKLIEF® cream in the treatment of acne vulgaris
Detailed Description
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) to AKLIEF® Cream and both active treatments to a placebo control in the treatment of acne vulgaris

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
762 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trifarotene Cream 0.005%
Arm Type
Experimental
Arm Description
The study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days.
Arm Title
AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories)
Arm Type
Active Comparator
Arm Description
The study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days.
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
The study medication will be applied topically once daily at bedtime to the affected areas of the face as a thin layer, avoiding contact with the mouth, eyes, and other mucous membranes, for 84 consecutive days.
Intervention Type
Drug
Intervention Name(s)
Trifarotene Cream 0.005%
Other Intervention Name(s)
Test Product
Intervention Description
The study medication will be self-applied topically, on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle
Intervention Description
The study medication will be self-applied topically, on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days
Intervention Type
Drug
Intervention Name(s)
AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories)
Other Intervention Name(s)
Reference Product
Intervention Description
The study medication will be self-applied topically, on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days
Primary Outcome Measure Information:
Title
Demonstration in Therapeutic Equivalence & Safety of the Investigational Product
Description
Percent change in the inflammatory (papules and pustules) & non-inflammatory (open and closed comedones) lesion counts
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects ages 12 to 17 years of age inclusive must have provided IRB approved written assent; Subjects must have a definite clinical diagnosis of acne vulgaris of severity grade 2, 3,or 4 as per the Investigator's Global Assessment (IGA) Subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face. Exclusion Criteria: Female Subjects who are pregnant, nursing or planning to become pregnant during study participation Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients. Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis,squamous cell carcinoma, eczema, acneiform eruptions caused by medications,steroid acne, steroid folliculitis, or bacterial folliculitis).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Yantovskiy
Organizational Affiliation
Taro Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Taro Pharmaceuticals USA Inc.
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris

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