Back to resultsA Study Comparing Adapalene Gel 0.1% and to Differin Gel in the Treatment of Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adapalene Gel 0.1%
Placebo Control
Differin® Gel (Adapalene 0.1%, Galderma)
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
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)
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
- Catawba Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Adapalene gel 0.1%
Differin® Gel (Adapalene 0.1%, Galderma)
Placebo Control
Arm 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.
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.
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.
Outcomes
Primary Outcome Measures
The percentage change in the inflammatory and non-inflammatory lesion counts
Demonstration of Therapeutic Equivalence
Secondary Outcome Measures
Full Information
NCT ID
NCT04797793
First Posted
March 12, 2021
Last Updated
March 26, 2021
Sponsor
Taro Pharmaceuticals USA
1. Study Identification
Unique Protocol Identification Number
NCT04797793
Brief Title
A Study Comparing Adapalene Gel 0.1% and to Differin Gel in the Treatment of Acne Vulgaris
Official Title
A Double-blind, Randomized, Placebo Controlled Study to Compare Adapalene Gel 0.1% to Differin Gel and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
January 8, 2021 (Actual)
Study Completion Date
January 8, 2021 (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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To demonstrate therapeutic equivalence and safety of adapalene gel 0.1% (Taro Pharmaceuticals U.S.A., Inc.) and Differin® Gel (Adapalene Gel 0.1%, Galderma) in the treatment of acne vulgaris.
Detailed Description
A multi-center, double-blind, randomized, placebo controlled, parallel-group study, Adapalene Gel 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and to Differin® Gel (Adapalene 0.1%, Galderma) 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
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
978 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adapalene gel 0.1%
Arm Type
Experimental
Arm 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.
Arm Title
Differin® Gel (Adapalene 0.1%, Galderma)
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm 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)
Adapalene Gel 0.1%
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 Control
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)
Differin® Gel (Adapalene 0.1%, Galderma)
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
The percentage change in the inflammatory and non-inflammatory lesion counts
Description
Demonstration of Therapeutic Equivalence
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)
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
Zaidoon A. Al-Zubaidy
Organizational Affiliation
Catawba Research
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
Learn more about this trial
A Study Comparing Adapalene Gel 0.1% and to Differin Gel in the Treatment of Acne Vulgaris
We'll reach out to this number within 24 hrs