A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)

Acne Vulgaris Clinical Trial

Official title:

A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-123 Lotion and IDP-123 Vehicle Lotion in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03168321
• Other study ID #: V01-123A-301
• Status: Completed
• Phase: Phase 3
• Start date: June 29, 2017
• Est. completion date: June 7, 2018

Study information

• Verified date: March 2021
• 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, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle Lotion.

Description:

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123 Vehicle Lotion. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 813
• Est. completion date: June 7, 2018
• Est. primary completion date: June 7, 2018
• 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 a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity 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 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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• IDP-123 Lotion
Tazarotene 0.045% Lotion
• IDP-123 Vehicle Lotion
Vehicle Lotion

Locations

Country	Name	City	State
Canada	Valeant Site 10	Laval	Quebec
Canada	Valeant Site 29	Peterborough	Ontario
Canada	Valeant Site 28	Waterloo	Ontario
United States	Valeant Site 06	Arlington Heights	Illinois
United States	Valeant Site 12	Austin	Texas
United States	Valeant Site 35	Boca Raton	Florida
United States	Valeant Site 30	Boise	Idaho
United States	Valeant Site 32	Cincinnati	Ohio
United States	Valeant Site 38	Detroit	Michigan
United States	Valeant Site 11	Dublin	Ohio
United States	valeant Site 07	Gresham	Oregon
United States	Valeant Site 09	High Point	North Carolina
United States	Valeant Site 24	Hot Springs	Arkansas
United States	Valeant Site 15	Johnston	Rhode Island
United States	Valeant Site 05	Katy	Texas
United States	Valeant Site 34	Knoxville	Tennessee
United States	Valeant Site 04	La Mesa	California
United States	Valeant Site 22	Louisville	Kentucky
United States	Valeant Site 02	Manhattan Beach	California
United States	Valeant Site 08	Metairie	Louisiana
United States	Valeant Site 42	Murrieta	California
United States	valeant Site 14	Nashville	Tennessee
United States	Valeant Site 23	New Albany	Indiana
United States	Valeant site 20	New York	New York
United States	Valeant Site 36	New York	New York
United States	Valeant Site 26	Newnan	Georgia
United States	Valeant Site 45	Norfolk	Virginia
United States	Valeant Site 40	North Miami Beach	Florida
United States	Valeant Site 33	Ormond Beach	Florida
United States	Valeant Site 31	Overland Park	Kansas
United States	Valeant Site 27	Pembroke Pines	Florida
United States	Valeant Site 19	Phoenix	Arizona
United States	Valeant Site 21	Phoenix	Arizona
United States	Valeant Site 18	Plano	Texas
United States	Valeant Site 39	Sacramento	California
United States	Valeant Site 41	Salt Lake City	Utah
United States	Valeant Site 25	San Antonio	Texas
United States	Valeant Site 01	San Diego	California
United States	Valeant Site 13	Sanford	Florida
United States	Valeant Site 17	South Bend	Indiana
United States	Valeant Site 44	Spokane	Washington
United States	Valeant Site 16	Warren	Michigan
United States	Valeant Site 43	Webster	Texas
United States	Valeant Site 03	West Palm Beach	Florida
United States	Valeant Site 37	Wheat Ridge	Colorado

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 in Mean Lesion Counts at Week 12	For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.	Baseline to Week 12
Primary	Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear"	Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.	Baseline to Week 12
Secondary	Percentage Change in Mean Lesion Counts at Week 12	For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.	Baseline to Week 12
Secondary	Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)	Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.	Baseline to Week 12
Secondary	Percentage Change in Mean Lesion Counts at Week 8	For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.	Baseline to Week 8
Secondary	Percentage Change in Mean Lesion Counts at Week 4	For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.	Baseline to Week 4