Clinical trial NCT04214639: Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris
Official title: A Phase 3, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-02
Enrollment: 183
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Absolute Change From Baseline to Week 12 in Inflammatory Lesion Counts
timeFrame: 12 weeks
measure: Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
timeFrame: 12 weeks
measure: Percentage of Participants With Success on the Evaluator's Global Severity Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12
timeFrame: Baseline to Week 4, 8, 12
measure: Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12
timeFrame: Baseline to Week 4, 8, 12
measure: Percentage of Participants With at Least a Two Grade Reduction on the Evaluator's Global Severity Score at Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bryant
country: United States
facility: Bausch Site 110
state: Arkansas
city: Fremont
country: United States
facility: Bausch Site 104
state: California
city: Denver
country: United States
facility: Bausch Site 109
state: Colorado
city: Boynton Beach
country: United States
facility: Bausch Site 102
state: Florida
city: North Miami Beach
country: United States
facility: Bausch Site 111
state: Florida
city: Sanford
country: United States
facility: Bausch Site 106
state: Florida
city: Las Vegas
country: United States
facility: Bausch Site 103
state: Nevada
city: New York
country: United States
facility: Bausch Site 114
state: New York
city: High Point
country: United States
facility: Bausch Site 105
state: North Carolina
city: Nashville
country: United States
facility: Bausch Site 107
state: Tennessee
city: Pflugerville
country: United States
facility: Bausch Site 108
state: Texas
city: Barrie
country: Canada
facility: Bausch Site 101
state: Ontario
city: Waterloo
country: Canada
facility: Bausch Site 113
state: Ontario
Study officials:
affiliation: Bausch Health
name: Anya Loncaric
role: STUDY_DIRECTOR
References: