Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel

Acne Vulgaris Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Clinical Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel (0.3% Adapalene/2.5% BPO), in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04892706
• Other study ID #: V01-126A-202
• Status: Completed
• Phase: Phase 2
• Start date: June 11, 2021
• Est. completion date: September 28, 2022

Study information

• Verified date: August 2023
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The safety and efficacy of once daily application of IDP 126 Gel will be compared to Epiduo® Forte and IDP-126 Vehicle Gel.

Description:

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 with Epiduo® Forte gel and IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study, subjects must be at least 12 years of age and have a clinical diagnosis of moderate to severe acne (defined as an Evaluator's Global Severity Score [EGSS] of 3 or 4), presenting with 30-100 inflammatory facial lesions (papules, pustules, and nodules), 35-150 non-inflammatory facial lesions (open and closed comedones), and ≤ 2 facial nodules.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 686
• Est. completion date: September 28, 2022
• Est. primary completion date: September 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 99 Years

Eligibility

Inclusion Criteria:

• Male or female at least 12 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 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
Gel applied to face once daily in the evening.
• IDP-126 Vehicle Gel
Gel applied to face once daily in the evening.
• Epiduo® Forte Gel
Gel applied to face once daily in the evening.

Locations

Country	Name	City	State
Belgium	Bausch Site 136	Kortrijk
Belgium	Bausch Site 140	Maldegem
Canada	Bausch Site 125	Markham	Ontario
Canada	Bausch Site 141	Oakville	Ontario
Canada	Bausch Site 115	Peterborough	Ontario
Canada	Bausch Site 113	Saint-Jérôme	Quebec
Canada	Bausch Site 130	Waterloo	Ontario
Canada	Bausch Site 138	Winnipeg	Manitoba
United States	Bausch Site 111	Austin	Texas
United States	Bausch Site 127	Boise	Idaho
United States	Bausch Site 105	Boynton Beach	Florida
United States	Bausch Site 103	Brighton	Massachusetts
United States	Bausch Site 134	Bryant	Arkansas
United States	Bausch Site 126	Clearwater	Florida
United States	Bausch Site 109	Dublin	Ohio
United States	Bausch Site 110	Fremont	California
United States	Bausch Site 107	Gresham	Oregon
United States	Bausch Site 142	High Point	North Carolina
United States	Bausch Site 132	Houston	Texas
United States	Bausch Site 108	Las Vegas	Nevada
United States	Bausch Site 129	Louisville	Kentucky
United States	Bausch Site 139	Mandeville	Louisiana
United States	Bausch Site 101	Manhattan Beach	California
United States	Bausch Site 121	Metairie	Louisiana
United States	Bausch Site 114	Nashville	Tennessee
United States	Bausch Site 120	New Brighton	Minnesota
United States	Bausch Site 119	New York	New York
United States	Bausch Site 133	New York	New York
United States	Bausch Site 124	Newnan	Georgia
United States	Bausch Site 135	North Miami Beach	Florida
United States	Bausch Site 117	Oklahoma City	Oklahoma
United States	Bausch Site 123	Pflugerville	Texas
United States	Bausch Site 116	Rockville	Maryland
United States	Bausch Site 118	Rogers	Arkansas
United States	Bausch Site 106	San Diego	California
United States	Bausch Site 112	San Diego	California
United States	Bausch Site 128	San Diego	California
United States	Bausch Site 143	Sanford	Florida
United States	Bausch Site 137	Spokane	Washington
United States	Bausch Site 102	Tampa	Florida
United States	Bausch Site 104	West Palm Beach	Florida
United States	Bausch Site 122	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from Baseline to Week 12 in lesion counts.		Baseline to Week 12
Primary	Percentage of subjects who achieve at least a two-grade reduction from baseline and are "Clear" or "Almost Clear" at Week 12 in the Evaluator's Global Severity Score.	EGSS evaluations will be scored on a scale of 0-4, with 0 being clear and 4 being severe.	Baseline to Week 12