Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

NCT02965456 | Completed Phase 3 Results

• 1 other identifier: V01-121A-302
• Study Type: interventional
• Target: 820
• Locations: 1 country
• Sites: 34

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 \[severe\]).

Conditions

Acne

Outcome Measures

Primary Outcomes (3)

• Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12

  Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.

  Baseline (Day 0), Week 12

• Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12

  Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.

  Baseline, Week 12

• Percentage of Participants With Treatment Success at Week 12

  Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.

  Baseline, Week 12

Secondary Outcomes (2)

• Percent Change From Baseline in Noninflammatory Lesion Count to Week 12

  Baseline, Week 12

• Percent Change From Baseline in Inflammatory Lesion Count to Week 12

  Baseline, Week 12

Study Arms (2)

IDP-121 Lotion

EXPERIMENTAL

IDP-121 lotion (tretinoin 0.05 percent \[%\]) will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.

Drug: IDP 121 Lotion

IDP-121 Vehicle Lotion

PLACEBO COMPARATOR

IDP-121 lotion vehicle will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.

Drug: IDP-121 Vehicle Lotion

Interventions

IDP 121 Lotion DRUG

IDP-121 lotion will be applied as per the instructions provided by the investigational center staff.

IDP-121 Lotion

IDP-121 Vehicle Lotion DRUG

IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff.

IDP-121 Vehicle Lotion

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (34)

Valeant Site 21

Glendale, Arizona, 85308, United States

Location

Valeant Site 34

Rogers, Arkansas, 72758, United States

Location

Valeant Site 25

Anaheim, California, 92801, United States

Location

Valeant Site 18

Beverly Hills, California, 90210, United States

Location

Valeant Site 09

Fremont, California, 94538, United States

Location

Valeant Site 17

Murrieta, California, 92526, United States

Location

Valeant Site 26

Oxnard, California, 93035, United States

Location

Valeant Site 22

Sacramento, California, 95819, United States

Location

Valeant Site 02

San Diego, California, 92123, United States

Location

Valeant Site 04

San Diego, California, 92123, United States

Location

Valeant Site 19

Santa Monica, California, 90404, United States

Location

Valeant Site 15

Miami, Florida, 33015, United States

Location

Valeant Site 11

Miami, Florida, 33144, United States

Location

Valeant Site 27

Pinellas Park, Florida, 33782, United States

Location

Valeant Site 31

Sanford, Florida, 32771, United States

Location

Valeant Site 05

Tampa, Florida, 33624, United States

Location

Valeant Site 28

Marietta, Georgia, 30060, United States

Location

Valeant Site 16

Buffalo Grove, Illinois, 60089, United States

Location

Valeant Site 06

Indianapolis, Indiana, 46256, United States

Location

Valeant Site 12

Overland Park, Kansas, 66215, United States

Location

Valeant Site 32

Crowley, Louisiana, 70526, United States

Location

Valeant Site 30

Clarkston, Michigan, 48346, United States

Location

Valeant Site 03

Detroit, Michigan, 48302, United States

Location

Valeant Site 20

Henderson, Nevada, 89074, United States

Location

Valeant Site 08

New York, New York, 10016, United States

Location

Valeant Site 23

Winston-Salem, North Carolina, 27104, United States

Location

Valeant Site 29

Hazleton, Pennsylvania, 18201, United States

Location

Valeant Site 24

Johnston, Rhode Island, 02919, United States

Location

Valeant Site 10

Austin, Texas, 78759, United States

Location

Valeant Site 01

Houston, Texas, 77065, United States

Location

Valeant Site 33

Port Arthur, Texas, 77460, United States

Location

Valeant Site 07

San Antonio, Texas, 78229, United States

Location

Valeant Site 13

San Antonio, Texas, 78229, United States

Location

Valeant Site 14

San Antonio, Texas, 78249, United States

Location

Related Publications (1)

• 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.

  PMID: 32886337 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Clinical Operations Director
• Organization: Bausch Health Americas, Inc.

aloncaric@bauschhealth.com

1-510-259-5284

Study Officials

• Tim Theisen

  TKL Research, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: November 16, 2016
• Study Start: November 4, 2015
• Primary Completion: February 23, 2017
• Study Completion: February 23, 2017
• Last Updated: December 18, 2019
• Results First Posted: December 18, 2019

Record last verified: 2019-12

Locations

US (34)