Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

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, tolerability, and efficacy of IDP-126 Gel in comparison IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12.

Key facts

Study ID

NCT04214639

Run by

Bausch Health Americas, Inc.

People needed

183

Starts

2020-01-17

Expected to finish

2021-01-18

Last updated by the study team

2024-02-01

Who can join

Age: 9 and older. 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 an Evaluator's Global Severity Score (EGSS) of 3 (moderate) or 4 (severe) at the baseline visit.
• Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 30, but no more than 100.
• Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 35, but no more than 150.
• Subjects with 2 or fewer facial nodules.

You may not qualify if…

• 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 more than 2 facial nodules.
• Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study.
• Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 12 weeks immediately preceding study entry; subjects treated with estrogens 12 or more consecutive weeks immediately prior to study entry need not be excluded unless the subject expects to change dose, drug or discontinue estrogen use during the study.
• Treatment of any type of cancer within the last 6 months, with the exception of complete surgical excision of skin cancer outside the treatment area.
• Subjects who have not undergone specified washout period(s) for topical preparations/physical treatments used on the face or subjects who require the concurrent use in the treatment area.
• Subjects who have not undergone specified washout period(s) for systemic medications or subjects who require the concurrent use of systemic medications.
• Subjects with any underlying disease that the investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study.

Where it is running

• Bausch Site 110 — Bryant, Arkansas, United States
• Bausch Site 104 — Fremont, California, United States
• Bausch Site 109 — Denver, Colorado, United States
• Bausch Site 102 — Boynton Beach, Florida, United States
• Bausch Site 111 — North Miami Beach, Florida, United States
• Bausch Site 106 — Sanford, Florida, United States
• Bausch Site 103 — Las Vegas, Nevada, United States
• Bausch Site 114 — New York, New York, United States
• Bausch Site 105 — High Point, North Carolina, United States
• Bausch Site 107 — Nashville, Tennessee, United States
• Bausch Site 108 — Pflugerville, Texas, United States
• Bausch Site 101 — Barrie, Ontario, Canada
• Bausch Site 113 — Waterloo, Ontario, Canada

Full record on ClinicalTrials.gov

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