Clinical trial NCT04892706: Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Clinical Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel (0.3% Adapalene/2.5% BPO), in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-19
Enrollment: 686
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The safety and efficacy of once daily application of IDP 126 Gel will be compared to Epiduo® Forte and IDP-126 Vehicle Gel.

Detailed description: 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 with Epiduo® Forte gel and IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study, subjects must be at least 12 years of age and have a clinical diagnosis of moderate to severe acne (defined as an Evaluator's Global Severity Score \[EGSS\] of 3 or 4), presenting with 30-100 inflammatory facial lesions (papules, pustules, and nodules), 35-150 non-inflammatory facial lesions (open and closed comedones), and ≤ 2 facial nodules.

Eligibility criteria: Inclusion Criteria:

* Male or female at least 12 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 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 lesion counts.
timeFrame: Baseline to Week 12
measure: Percentage of subjects who achieve at least a two-grade reduction from baseline and are "Clear" or "Almost Clear" at Week 12 in the Evaluator's Global Severity Score.
timeFrame: Baseline to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Bryant
country: United States
facility: Bausch Site 134
state: Arkansas
city: Rogers
country: United States
facility: Bausch Site 118
state: Arkansas
city: Fremont
country: United States
facility: Bausch Site 110
state: California
city: Manhattan Beach
country: United States
facility: Bausch Site 101
state: California
city: San Diego
country: United States
facility: Bausch Site 106
state: California
city: San Diego
country: United States
facility: Bausch Site 112
state: California
city: San Diego
country: United States
facility: Bausch Site 128
state: California
city: Boynton Beach
country: United States
facility: Bausch Site 105
state: Florida
city: Clearwater
country: United States
facility: Bausch Site 126
state: Florida
city: North Miami Beach
country: United States
facility: Bausch Site 135
state: Florida
city: Sanford
country: United States
facility: Bausch Site 143
state: Florida
city: Tampa
country: United States
facility: Bausch Site 102
state: Florida
city: West Palm Beach
country: United States
facility: Bausch Site 104
state: Florida
city: West Palm Beach
country: United States
facility: Bausch Site 122
state: Florida
city: Newnan
country: United States
facility: Bausch Site 124
state: Georgia
city: Boise
country: United States
facility: Bausch Site 127
state: Idaho
city: Louisville
country: United States
facility: Bausch Site 129
state: Kentucky
city: Mandeville
country: United States
facility: Bausch Site 139
state: Louisiana
city: Metairie
country: United States
facility: Bausch Site 121
state: Louisiana
city: Rockville
country: United States
facility: Bausch Site 116
state: Maryland
city: Brighton
country: United States
facility: Bausch Site 103
state: Massachusetts
city: New Brighton
country: United States
facility: Bausch Site 120
state: Minnesota
city: Las Vegas
country: United States
facility: Bausch Site 108
state: Nevada
city: New York
country: United States
facility: Bausch Site 119
state: New York
city: New York
country: United States
facility: Bausch Site 133
state: New York
city: High Point
country: United States
facility: Bausch Site 142
state: North Carolina
city: Dublin
country: United States
facility: Bausch Site 109
state: Ohio
city: Oklahoma City
country: United States
facility: Bausch Site 117
state: Oklahoma
city: Gresham
country: United States
facility: Bausch Site 107
state: Oregon
city: Nashville
country: United States
facility: Bausch Site 114
state: Tennessee
city: Austin
country: United States
facility: Bausch Site 111
state: Texas
city: Houston
country: United States
facility: Bausch Site 132
state: Texas
city: Pflugerville
country: United States
facility: Bausch Site 123
state: Texas
city: Spokane
country: United States
facility: Bausch Site 137
state: Washington
city: Kortrijk
country: Belgium
facility: Bausch Site 136
city: Maldegem
country: Belgium
facility: Bausch Site 140
city: Winnipeg
country: Canada
facility: Bausch Site 138
state: Manitoba
city: Markham
country: Canada
facility: Bausch Site 125
state: Ontario
city: Oakville
country: Canada
facility: Bausch Site 141
state: Ontario
city: Peterborough
country: Canada
facility: Bausch Site 115
state: Ontario
city: Waterloo
country: Canada
facility: Bausch Site 130
state: Ontario
city: Saint-Jérôme
country: Canada
facility: Bausch Site 113
state: Quebec
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Varsha Bhatt
role: STUDY_DIRECTOR
References: