Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03664752
• Collaborator: (none)
• Enrollment: 585
• Locations: 20
• Arms: 2
• Actual Duration (Months): 16.9
• Patients Per Site: 29.3
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: IDP-120 Gel; Drug: IDP-120 Vehicle Gel	Phase 3

Detailed Description

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne

Study Design

• Study Type: Interventional
• Actual Enrollment: 585 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group StudyMulti-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) As a double-blinded study, the investigators, the site staff, the sponsor, and the clinical monitors will not be aware of the treatment assigned to the individual study subjects
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris
• Actual Study Start Date: Dec 10, 2018
• Actual Primary Completion Date: May 7, 2020
• Actual Study Completion Date: May 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IDP-120 Gel Component A	Drug: IDP-120 Gel; Component A
Placebo Comparator: IDP-120 vehicle gel Vehicle	Drug: IDP-120 Vehicle Gel; Vehicle

Outcome Measures

Primary Outcome Measures

1. Inflammatory lesion counts [Change from Baseline to Week 12 (end of study)]

   Superiority in absolute change from Baseline to Week 12 in mean inflammatory lesion counts

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

2. 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);

3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity Score (EGSS) assessment at the baseline visit;

4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;

5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;

6. Subjects with two or fewer facial nodules

Exclusion Criteria:

1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;

2. 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;

3. 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;

4. Subjects with a facial beard or mustache that could interfere with the study assessments;

5. Subjects with more than two (2) facial nodules;

6. Evidence or history of cosmetic-related acne

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Valeant Site 210	Rogers	Arkansas	United States	72758
2	Valeant Site 201	Manhattan Beach	California	United States	90266
3	Valeant Site 206	San Diego	California	United States	92123
4	Valeant Site 218	San Diego	California	United States	92123
5	Valeant Site 204	Boynton Beach	Florida	United States	33437
6	Valeant Site 217	Brandon	Florida	United States	33511
7	Valeant Site 202S	Miami	Florida	United States	33144
8	Valeant Site 214	Tampa	Florida	United States	33606
9	Valeant Site 222	Snellville	Georgia	United States	30078
10	Valeant Site 215	Boise	Idaho	United States	83704
11	Valeant Site 205	Metairie	Louisiana	United States	70006
12	Valeant Site 216	Clarkston	Michigan	United States	48346
13	Valeant Site 221	Clinton Township	Michigan	United States	48038
14	Valeant Site 227	Rochester	New York	United States	14623
15	Valeant Site 229	Raleigh	North Carolina	United States	27612
16	Valeant Site 230	Raleigh	North Carolina	United States	27612
17	Valeant Site 213	San Antonio	Texas	United States	78213
18	Valeant Site 223	Spokane	Washington	United States	99202
19	Valeant Site 219	Waterloo	Ontario	Canada	N2J 1C4
20	Valeant Site 228	Waterloo	Ontario	Canada	N2J 1C4

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

• Study Director: Anya Loncaric, Bausch Health Companies

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT03664752
• Other Study ID Numbers: V01-120A-302
• First Posted: Sep 10, 2018
• Last Update Posted: May 10, 2021
• Last Verified: May 1, 2021

• 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 May 10, 2021