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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04883736
• Other study ID #: TRTN-1619
• Status: Completed
• Phase: Early Phase 1
• Start date: August 31, 2020
• Est. completion date: April 16, 2021

Study information

• Verified date: May 2021
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 973
• Est. completion date: April 16, 2021
• Est. primary completion date: April 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Tretinoin Gel Microsphere, 0.1%
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.
• RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1%
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.
• Placebo Control
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.

Locations

Country	Name	City	State
United States	Catawba Research, LLC	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage change in the inflammatory and non-inflammatory lesion counts	Demonstration of Therapeutic Equivalence	Baseline to Week 12