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

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04214652
• Collaborator: (none)
• Enrollment: 180
• Locations: 13
• Arms: 2
• Actual Duration (Months): 13.7
• Patients Per Site: 13.8
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: IDP-126 Gel; Drug: IDP-126 Vehicle Gel	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 27, 2020
• Actual Primary Completion Date: Mar 18, 2021
• Actual Study Completion Date: Mar 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IDP-126 Gel	Drug: IDP-126 Gel; IDP-126 Gel applied topically to the face once daily for 12 weeks.
Placebo Comparator: IDP-126 Vehicle Gel	Drug: IDP-126 Vehicle Gel; IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.

Outcome Measures

Primary Outcome Measures

1. Absolute change from Baseline to Week 12 in inflammatory lesion counts [12 weeks]

2. Absolute change from Baseline to Week 12 in non-inflammatory lesion counts [12 weeks]

3. 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) [12 weeks]

   EGSS evaluations will be scored on a scale of 0-4, with 0 being clear and 4 being severe.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch Site 205	Rogers	Arkansas	United States	72758
2	Bausch Site 201	Manhattan Beach	California	United States	90266
3	Bausch Site 207	West Palm Beach	Florida	United States	33406
4	Bausch Site 208	Boise	Idaho	United States	83704
5	Bausch Site 209	Louisville	Kentucky	United States	40241
6	Bausch Site 202	Brighton	Massachusetts	United States	21350
7	Bausch Site 212	Detroit	Michigan	United States	48202
8	Bausch Site 206	New York	New York	United States	10022
9	Bausch Site 203	Gresham	Oregon	United States	97030
10	Bausch Site 204	Johnston	Rhode Island	United States	29190
11	Bausch Site 213	Winnipeg	MN	Canada	R3M 3Z4
12	Bausch Site 210	Oakville	Ontario	Canada	L6J 7W5
13	Bausch Site 211	Peterborough	Ontario	Canada	K9J 5K2

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

• Study Director: Anya Loncaric, Bausch Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT04214652
• Other Study ID Numbers: V01-126A-302
• First Posted: Jan 2, 2020
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acne Vulgaris

Study Results

No Results Posted as of Mar 16, 2022