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

Completed · Phase 3

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT03168321

Run by

Bausch Health Americas, Inc.

People needed

813

Starts

2017-06-29

Expected to finish

2018-06-07

Last updated by the study team

2021-04-01

Who can join

Age: 9 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the baseline visit;
• Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;
• Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;
• Subjects with two or fewer nodules

You may not qualify if…

• Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;
• 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 a facial beard or mustache that could interfere with the study assessments;
• Subjects with more than two (2) facial nodules;
• Evidence or history of cosmetic-related acne

Where it is running

• Valeant Site 19 — Phoenix, Arizona, United States
• Valeant Site 21 — Phoenix, Arizona, United States
• Valeant Site 24 — Hot Springs, Arkansas, United States
• Valeant Site 04 — La Mesa, California, United States
• Valeant Site 02 — Manhattan Beach, California, United States
• Valeant Site 42 — Murrieta, California, United States
• Valeant Site 39 — Sacramento, California, United States
• Valeant Site 01 — San Diego, California, United States
• Valeant Site 37 — Wheat Ridge, Colorado, United States
• Valeant Site 35 — Boca Raton, Florida, United States
• Valeant Site 40 — North Miami Beach, Florida, United States
• Valeant Site 33 — Ormond Beach, Florida, United States
• Valeant Site 27 — Pembroke Pines, Florida, United States
• Valeant Site 13 — Sanford, Florida, United States
• Valeant Site 03 — West Palm Beach, Florida, United States
• Valeant Site 26 — Newnan, Georgia, United States
• Valeant Site 30 — Boise, Idaho, United States
• Valeant Site 06 — Arlington Heights, Illinois, United States
• Valeant Site 23 — New Albany, Indiana, United States
• Valeant Site 17 — South Bend, Indiana, United States
• Valeant Site 31 — Overland Park, Kansas, United States
• Valeant Site 22 — Louisville, Kentucky, United States
• Valeant Site 08 — Metairie, Louisiana, United States
• Valeant Site 38 — Detroit, Michigan, United States
• Valeant Site 16 — Warren, Michigan, United States

Full record on ClinicalTrials.gov

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