search
Back to results

A Study Comparing Tretinoin Gel Microsphere, 0.1% and RETIN-A MICRO ® Gel Microsphere, 0.1% in the Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tretinoin Gel Microsphere, 0.1%
RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1%
Placebo Control
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)

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

Tretinoin Gel Microsphere, 0.1%

RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1%

Placebo Control

Arm Description

The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, 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 in the evening, 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 in the evening, 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

First Posted
May 7, 2021
Last Updated
May 7, 2021
Sponsor
Taro Pharmaceuticals USA
search

1. Study Identification

Unique Protocol Identification Number
NCT04883736
Brief Title
A Study Comparing Tretinoin Gel Microsphere, 0.1% and RETIN-A MICRO ® Gel Microsphere, 0.1% in the Treatment of Acne Vulgaris
Official Title
A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) to RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
April 16, 2021 (Actual)
Study Completion Date
April 16, 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 the therapeutic equivalence and safety of Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) in the treatment of acne vulgaris.
Detailed Description
A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) 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
973 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tretinoin Gel Microsphere, 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 in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
Arm Title
RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1%
Arm Type
Active Comparator
Arm Description
The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, 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 in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
Intervention Type
Drug
Intervention Name(s)
Tretinoin Gel Microsphere, 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 in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
Intervention Type
Drug
Intervention Name(s)
RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1%
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 in the evening, 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 in the evening, 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 Tretinoin Gel Microsphere, 0.1% and RETIN-A MICRO ® Gel Microsphere, 0.1% in the Treatment of Acne Vulgaris

We'll reach out to this number within 24 hrs