Clinical trial NCT04214652: 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: 180
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: Rogers
country: United States
facility: Bausch Site 205
state: Arkansas
city: Manhattan Beach
country: United States
facility: Bausch Site 201
state: California
city: West Palm Beach
country: United States
facility: Bausch Site 207
state: Florida
city: Boise
country: United States
facility: Bausch Site 208
state: Idaho
city: Louisville
country: United States
facility: Bausch Site 209
state: Kentucky
city: Brighton
country: United States
facility: Bausch Site 202
state: Massachusetts
city: Detroit
country: United States
facility: Bausch Site 212
state: Michigan
city: New York
country: United States
facility: Bausch Site 206
state: New York
city: Gresham
country: United States
facility: Bausch Site 203
state: Oregon
city: Johnston
country: United States
facility: Bausch Site 204
state: Rhode Island
city: Winnipeg
country: Canada
facility: Bausch Site 213
state: MN
city: Oakville
country: Canada
facility: Bausch Site 210
state: Ontario
city: Peterborough
country: Canada
facility: Bausch Site 211
state: Ontario
Study officials:
affiliation: Bausch Health
name: Anya Loncaric
role: STUDY_DIRECTOR
References: