A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302)

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: NCT03168334
• Other study ID #: V01-123A-302
• Status: Completed
• Phase: Phase 3
• Start date: July 11, 2017
• Est. completion date: July 24, 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 multi-center, 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: 801
• Est. completion date: July 24, 2018
• Est. primary completion date: July 24, 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 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

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 17	Saint-Jérôme	Quebec
Canada	Valeant Site 01	Surrey	British Columbia
Canada	Valeant Site 40	Windsor	Ontario
Canada	Valeant Site 45	Winnipeg	Manitoba
United States	Valeant Site 42	Albuquerque	New Mexico
United States	Valeant Site 08	Bay City	Michigan
United States	Valeant Site 05	Boynton Beach	Florida
United States	Valeant Site 28	Broomall	Pennsylvania
United States	Valeant Site 34	Carlsbad	California
United States	Valeant Site 21	Charlottesville	Virginia
United States	Valeant Site 30	Clarkston	Michigan
United States	Valeant Site 29	Clearwater	Florida
United States	Valeant Site 37	Clinton Township	Michigan
United States	Valeant Site 23	College Station	Texas
United States	Valeant Site 07	Dallas	Texas
United States	Valeant Site 25	Denver	Colorado
United States	Valeant Site 20	Fort Gratiot	Michigan
United States	Valeant Site 12	Fremont	California
United States	Valeant Site 24	Fridley	Minnesota
United States	Valeant Site 38	Jupiter	Florida
United States	Valeant Site 18	Knoxville	Tennessee
United States	Valeant Site 09	Layton	Utah
United States	Valeant Site 32	Louisville	Kentucky
United States	Valeant Site 02	Miami	Florida
United States	Valeant Site 41	Mobile	Alabama
United States	Valeant Site 03	Morristown	New Jersey
United States	Valeant Site 14	Murfreesboro	Tennessee
United States	Valeant Site 10	New York	New York
United States	Valeant Site 11	Oklahoma City	Oklahoma
United States	Valeant Site 27	Pflugerville	Texas
United States	Valeant Site 43	Rochester	New York
United States	Valeant Site 19	Rockville	Maryland
United States	Valeant Site 22	Rogers	Arkansas
United States	Valeant Site 04	San Antonio	Texas
United States	Valeant Site 06	San Diego	California
United States	Valeant Site 13	San Diego	California
United States	Valeant Site 31	San Diego	California
United States	Valeant Site 36	Santa Ana	California
United States	Valeant Site 44	Snellville	Georgia
United States	Valeant Site 33	Stony Brook	New York
United States	Valeant Site 39	Sugar Land	Texas
United States	Valeant Site 35	Walla Walla	Washington
United States	Valeant Site 16	Warwick	Rhode Island
United States	Valeant Site 15	West Jordan	Utah
United States	Valeant Site 26	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	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