Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04214652
• Other study ID #: V01-126A-302
• Status: Completed
• Phase: Phase 3
• Start date: January 27, 2020
• Est. completion date: March 18, 2021

Study information

• Verified date: January 2024
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-126 Gel in comparison IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 18, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

Inclusion Criteria:

• Male or female at least 9 years of age and older.

• Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit).

• Subject must have an Evaluator's Global Severity Score (EGSS) of 3 (moderate) or 4 (severe) at the baseline visit.

• Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 30, but no more than 100.

• Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 35, but no more than 150.

• Subjects with 2 or fewer facial nodules.

Exclusion Criteria:

• Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram negative folliculitis, dermatitis, eczema.

• Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.

• Subjects with more than 2 facial nodules.

• Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study.

• Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 12 weeks immediately preceding study entry; subjects treated with estrogens 12 or more consecutive weeks immediately prior to study entry need not be excluded unless the subject expects to change dose, drug or discontinue estrogen use during the study.

• Treatment of any type of cancer within the last 6 months, with the exception of complete surgical excision of skin cancer outside the treatment area.

• Subjects who have not undergone specified washout period(s) for topical preparations/physical treatments used on the face or subjects who require the concurrent use in the treatment area.

• Subjects who have not undergone specified washout period(s) for systemic medications or subjects who require the concurrent use of systemic medications.

• Subjects with any underlying disease that the investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• IDP-126 Gel
IDP-126 Gel applied topically to the face once daily for 12 weeks.
• IDP-126 Vehicle Gel
IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.

Locations

Country	Name	City	State
Canada	Bausch Site 210	Oakville	Ontario
Canada	Bausch Site 211	Peterborough	Ontario
Canada	Bausch Site 213	Winnipeg	MN
United States	Bausch Site 208	Boise	Idaho
United States	Bausch Site 202	Brighton	Massachusetts
United States	Bausch Site 212	Detroit	Michigan
United States	Bausch Site 203	Gresham	Oregon
United States	Bausch Site 204	Johnston	Rhode Island
United States	Bausch Site 209	Louisville	Kentucky
United States	Bausch Site 201	Manhattan Beach	California
United States	Bausch Site 206	New York	New York
United States	Bausch Site 205	Rogers	Arkansas
United States	Bausch Site 207	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline to Week 12 in Inflammatory Lesion Counts		12 weeks
Primary	Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts		12 weeks
Primary	Percentage of Participants With Success on the Evaluator's Global Severity Score	Success was defined as at least a two grade reduction and clear or almost clear at Week 12. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.	12 weeks
Secondary	Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12		Baseline to Week 4, 8, 12
Secondary	Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12		Baseline to Week 4, 8, 12
Secondary	Percentage of Participants With at Least a Two Grade Reduction on the Evaluator's Global Severity Score at Week 12	The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.	12 weeks