Clinical trial NCT02932306: 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: 2016-10-13
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).
* Participant must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at the screening and baseline visit

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, gram-negative 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.

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: Guntersville
country: United States
facility: Valeant Site 36
state: Alabama
city: Phoenix
country: United States
facility: Valeant Site 14
state: Arizona
city: Hot Springs
country: United States
facility: Valeant Site 28
state: Arkansas
city: Fountain Valley
country: United States
facility: Valeant Site 38
state: California
city: Manhattan Beach
country: United States
facility: Valeant Site 34
state: California
city: Oceanside
country: United States
facility: Valeant Site 23
state: California
city: Rancho Cucamonga
country: United States
facility: Valeant Site 35
state: California
city: San Diego
country: United States
facility: Valeant Site 20
state: California
city: Denver
country: United States
facility: Valeant Site 32
state: Colorado
city: Shelton
country: United States
facility: Valeant Site 10
state: Connecticut
city: Boynton Beach
country: United States
facility: Valeant Site 02
state: Florida
city: Coral Gables
country: United States
facility: Valeant Site 15
state: Florida
city: Miami
country: United States
facility: Valeant Site 37
state: Florida
city: Pembroke Pines
country: United States
facility: Valeant Site 39
state: Florida
city: West Palm Beach
country: United States
facility: Valeant Site 01
state: Florida
city: Boise
country: United States
facility: Valeant Site 19
state: Idaho
city: Arlington Heights
country: United States
facility: Valeant Site 04
state: Illinois
city: Carmel
country: United States
facility: Valeant Site 27
state: Indiana
city: Plainfield
country: United States
facility: Valeant 12
state: Indiana
city: Louisville
country: United States
facility: Valeant Site 09
state: Kentucky
city: Louisville
country: United States
facility: Valeant Site 16
state: Kentucky
city: Needham
country: United States
facility: Valeant Site 33
state: Massachusetts
city: Warren
country: United States
facility: Valeant Site 11
state: Michigan
city: Omaha
country: United States
facility: Valeant Site 08
state: Nebraska
city: Omaha
country: United States
facility: Valeant Site 25
state: Nebraska
city: Berlin
country: United States
facility: Valeant Site 13
state: New Jersey
city: Albuquerque
country: United States
facility: Valeant Site 03
state: New Mexico
city: New York
country: United States
facility: Valeant Site 26
state: New York
city: Stony Brook
country: United States
facility: Valeant Site 31
state: New York
city: Gresham
country: United States
facility: Valeant 05
state: Oregon
city: Fort Washington
country: United States
facility: Valeant Site 22
state: Pennsylvania
city: Charleston
country: United States
facility: Valeant Site 24
state: South Carolina
city: Dallas
country: United States
facility: Valeant Site 06
state: Texas
city: Houston
country: United States
facility: Valeant Site 30
state: Texas
city: Pflugerville
country: United States
facility: Valeant Site 17
state: Texas
city: San Antonio
country: United States
facility: Valeant Site 07
state: Texas
city: Webster
country: United States
facility: Valeant 18
state: Texas
city: Salt Lake City
country: United States
facility: Valeant Site 29
state: Utah
city: Norfolk
country: United States
facility: Valeant Site 21
state: Virginia
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.