Clinical trial NCT02965456: Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-16
Enrollment: 820
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: The objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an Evaluator's Global Severity Score \[EGSS\] of 3 \[moderate\] or 4 \[severe\]).


Eligibility criteria: Key Inclusion Criteria:

* Male or female at least 9 years of age and older.
* Written and verbal informed consent must be obtained. Participants 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 participant reaches age of consent during the study they should be re-consented at the next study visit).
* Participants must be willing to comply with study instructions and return to the study center for required visits. Participants 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, participants must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the participant 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.
* Participants with a facial beard or mustache that could interfere with the study assessments.
* History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure, including known sensitivities to any dosage form of tretinoin.
* Participants who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.
* Participants with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the participant's safety while participating in the study.

Primary outcomes:
measure: Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12
timeFrame: Baseline (Day 0), Week 12
measure: Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants With Treatment Success at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Noninflammatory Lesion Count to Week 12
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in Inflammatory Lesion Count to Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Valeant Site 21
state: Arizona
city: Rogers
country: United States
facility: Valeant Site 34
state: Arkansas
city: Anaheim
country: United States
facility: Valeant Site 25
state: California
city: Beverly Hills
country: United States
facility: Valeant Site 18
state: California
city: Fremont
country: United States
facility: Valeant Site 09
state: California
city: Murrieta
country: United States
facility: Valeant Site 17
state: California
city: Oxnard
country: United States
facility: Valeant Site 26
state: California
city: Sacramento
country: United States
facility: Valeant Site 22
state: California
city: San Diego
country: United States
facility: Valeant Site 02
state: California
city: San Diego
country: United States
facility: Valeant Site 04
state: California
city: Santa Monica
country: United States
facility: Valeant Site 19
state: California
city: Miami
country: United States
facility: Valeant Site 15
state: Florida
city: Miami
country: United States
facility: Valeant Site 11
state: Florida
city: Pinellas Park
country: United States
facility: Valeant Site 27
state: Florida
city: Sanford
country: United States
facility: Valeant Site 31
state: Florida
city: Tampa
country: United States
facility: Valeant Site 05
state: Florida
city: Marietta
country: United States
facility: Valeant Site 28
state: Georgia
city: Buffalo Grove
country: United States
facility: Valeant Site 16
state: Illinois
city: Indianapolis
country: United States
facility: Valeant Site 06
state: Indiana
city: Overland Park
country: United States
facility: Valeant Site 12
state: Kansas
city: Crowley
country: United States
facility: Valeant Site 32
state: Louisiana
city: Clarkston
country: United States
facility: Valeant Site 30
state: Michigan
city: Detroit
country: United States
facility: Valeant Site 03
state: Michigan
city: Henderson
country: United States
facility: Valeant Site 20
state: Nevada
city: New York
country: United States
facility: Valeant Site 08
state: New York
city: Winston-Salem
country: United States
facility: Valeant Site 23
state: North Carolina
city: Hazleton
country: United States
facility: Valeant Site 29
state: Pennsylvania
city: Johnston
country: United States
facility: Valeant Site 24
state: Rhode Island
city: Austin
country: United States
facility: Valeant Site 10
state: Texas
city: Houston
country: United States
facility: Valeant Site 01
state: Texas
city: Port Arthur
country: United States
facility: Valeant Site 33
state: Texas
city: San Antonio
country: United States
facility: Valeant Site 07
state: Texas
city: San Antonio
country: United States
facility: Valeant Site 13
state: Texas
city: San Antonio
country: United States
facility: Valeant Site 14
state: Texas
Study officials:
affiliation: TKL Research, Inc.
name: Tim Theisen
role: STUDY_CHAIR
References:
citation: Tyring SK, Kircik L, Pariser DM, Woolery-Lloyd HC, Harper JC, Bhatt V, Pillai R, Guenin E. The Effects of Once-Daily Tretinoin 0.05% Lotion on Quality of Life in Patients with Moderate-to-Severe Acne Vulgaris. Am J Clin Dermatol. 2020 Dec;21(6):891-899. doi: 10.1007/s40257-020-00559-3.