A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A Phase 2, 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: NCT03170388
• Other study ID #: V01-126A-201
• Status: Completed
• Phase: Phase 2
• Start date: October 5, 2017
• Est. completion date: April 23, 2019

Study information

• Verified date: October 2021
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

Description:

A Phase 2, 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 741
• Est. completion date: April 23, 2019
• Est. primary completion date: April 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 99 Years

Eligibility

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 an EGSS of 3 (moderate) or 4 (severe) at the baseline visit.

4. Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20, but no more than 100.

5. Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than 150.

6. Subjects with 2 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 2 facial nodules.

6. Evidence or history of cosmetic-related acne.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• IDP-126 Gel
Gel
• IDP-126 Component A
Component A
• IDP-126 Component B
Component B
• IDP-126 Component C
Component C
• IDP-126 Vehicle Gel
Vehicle Gel

Locations

Country	Name	City	State
Canada	Valeant Site 05	Barrie	Ontario
Canada	Valeant Site 06	Oakville	Ontario
Canada	Valeant Site 04	Peterborough	Ontario
Canada	Valeant Site 03	Waterloo	Ontario
Canada	Valeant Site 01	Winnipeg	Manitoba
United States	Valeant Site 25	Albuquerque	New Mexico
United States	Valeant Site 32	Austin	Texas
United States	Valeant Site 16	Boise	Idaho
United States	Valeant Site 11	Boynton Beach	Florida
United States	Valeant Site 09	Denver	Colorado
United States	Valeant Site 22	Detroit	Michigan
United States	Valeant Site 07	Fremont	California
United States	valeant Site 21	Glenn Dale	Maryland
United States	Valeant Site 28	Gresham	Oregon
United States	Valeant Site 23	High Point	North Carolina
United States	Valeant Site 02	Hot Springs	Arkansas
United States	Valeant Site 30	Johnston	Rhode Island
United States	Valeant Site 18	Louisville	Kentucky
United States	Valeant Site 19	Louisville	Kentucky
United States	Valeant Site 15	Marietta	Georgia
United States	Valeant Site 24	Morristown	New Jersey
United States	Valeant Site 31	Nashville	Tennessee
United States	Valeant Site 20	Needham	Massachusetts
United States	Valeant Site 26	New York	New York
United States	Valeant Site 27	New York	New York
United States	Valeant Site 35	Norfolk	Virginia
United States	Valeant Site 13	North Miami Beach	Florida
United States	Valeant Site 17	Overland Park	Kansas
United States	Valeant Site 33	Pflugerville	Texas
United States	Valeant Site 08	Sacramento	California
United States	valeant Site 34	San Antonio	Texas
United States	Valeant Site 12	Sanford	Florida
United States	Valeant Site 14	Snellville	Georgia
United States	Valeant Site 10	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	Inflammatory Lesion Counts	Absolute change from Baseline to Week 12 in mean inflammatory lesion counts	Baseline to Week 12
Primary	Non-inflammatory Lesion Counts	Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts	Baseline to Week 12
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.	Baseline to Week 12
Secondary	Inflammatory Lesion Count Changes at Week 2, 4, and 8	Absolute change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts	Baseline to Week 2, 4, 8
Secondary	Non-inflammatory Lesion Count Changes at Week 2, 4, and 8	Absolute change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts	Baseline to Week 2, 4, 8
Secondary	Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8	Percentage change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts	Baseline to Week 2, 4, 8
Secondary	Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8	Percentage change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts	Baseline to Week 2, 4, 8
Secondary	Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8	Success was defined as at least a two grade reduction and clear or almost clear at the visit. 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.	Baseline to Week 2, 4, and 8
Secondary	Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8	Two grade success was defined as at least a two grade reduction. 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.	Baseline to Week 2, 4, and 8