Clinical trial NCT03003247: Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel 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: 2016-12-26
Enrollment: 364
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

Detailed description: A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

Eligibility criteria: Key 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)
* Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening visit, and a negative urine pregnancy test at baseline visit.
* Subjects must be willing to comply with study instructions and return to the clinic for required visits. Subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.
* If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the subject wears makeup they must agree to use non-comedogenic makeup.

Key Exclusion Criteria:

* 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, gramnegative folliculitis.
* 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.

Primary outcomes:
measure: Percent of subjects achieving clear or almost clear on the Evaluator's Global Severity Score.
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: Valeant Site 15
state: California
city: Lake Mary
country: United States
facility: Valeant Site 13
state: Florida
city: Miami
country: United States
facility: Valeant Site 16
state: Florida
city: Tampa
country: United States
facility: Valeant Site 14
state: Florida
city: West Palm Beach
country: United States
facility: Valeant Site 02
state: Florida
city: Atlanta
country: United States
facility: Valeant Site 21
state: Georgia
city: South Bend
country: United States
facility: Valeant Site 23
state: Indiana
city: Detroit
country: United States
facility: Valeant Site 09
state: Michigan
city: Minneapolis
country: United States
facility: Valeant Site 24
state: Minnesota
city: Saint Joseph
country: United States
facility: Valeant Site 11
state: Missouri
city: New York
country: United States
facility: Valreant Site 05
state: New York
city: New York
country: United States
facility: Valeant Site 06
state: New York
city: Chapel Hill
country: United States
facility: Valeant Site 01
state: North Carolina
city: High Point
country: United States
facility: Valeant Site 17
state: North Carolina
city: Columbus
country: United States
facility: Valeant Site 22
state: Ohio
city: Knoxville
country: United States
facility: Valeant Site 04
state: Tennessee
city: Austin
country: United States
facility: Valeant Site 07
state: Texas
city: Austin
country: United States
facility: Valeant Site 12
state: Texas
city: San Antonio
country: United States
facility: Valeant Site 18
state: Texas
city: Spokane
country: United States
facility: Valeant Site 25
state: Washington
city: Winnepeg
country: Canada
facility: Valeant Site 10
state: Manitoba
city: Markham
country: Canada
facility: Valeant Site 03
state: Ontario
city: Waterloo
country: Canada
facility: Valeant Site 08
state: Ontario
city: Windsor
country: Canada
facility: Valeant Site 20
state: Ontario
Study officials:
affiliation: Valeant Pharmaceuticals
name: Anya Loncaric
role: STUDY_DIRECTOR
References: