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

NCT02932306 | Completed Phase 3 Results FDA Drug

• 1 other identifier: V01-121A-301
• Study Type: interventional
• Target: 820
• Locations: 1 country
• Sites: 39

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).
• Participant must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at the screening and baseline visit

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, 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (39)

Valeant Site 36

Guntersville, Alabama, 35976, United States

Location

Valeant Site 14

Phoenix, Arizona, 85032, United States

Location

Valeant Site 28

Hot Springs, Arkansas, 71913, United States

Location

Valeant Site 38

Fountain Valley, California, 92708, United States

Location

Valeant Site 34

Manhattan Beach, California, 90266, United States

Location

Valeant Site 23

Oceanside, California, 92056, United States

Location

Valeant Site 35

Rancho Cucamonga, California, 91730, United States

Location

Valeant Site 20

San Diego, California, 92123, United States

Location

Valeant Site 32

Denver, Colorado, 80220, United States

Location

Valeant Site 10

Shelton, Connecticut, 06484, United States

Location

Valeant Site 02

Boynton Beach, Florida, 33437, United States

Location

Valeant Site 15

Coral Gables, Florida, 33146, United States

Location

Valeant Site 37

Miami, Florida, 33142, United States

Location

Valeant Site 39

Pembroke Pines, Florida, 33028, United States

Location

Valeant Site 01

West Palm Beach, Florida, 33401, United States

Location

Valeant Site 19

Boise, Idaho, 83704, United States

Location

Valeant Site 04

Arlington Heights, Illinois, 60005, United States

Location

Valeant Site 27

Carmel, Indiana, 46032, United States

Location

Valeant 12

Plainfield, Indiana, 46168, United States

Location

Valeant Site 09

Louisville, Kentucky, 40202, United States

Location

Valeant Site 16

Louisville, Kentucky, 40217, United States

Location

Valeant Site 33

Needham, Massachusetts, 02492, United States

Location

Valeant Site 11

Warren, Michigan, 48088, United States

Location

Valeant Site 08

Omaha, Nebraska, 68114, United States

Location

Valeant Site 25

Omaha, Nebraska, 68144, United States

Location

Valeant Site 13

Berlin, New Jersey, 08009, United States

Location

Valeant Site 03

Albuquerque, New Mexico, 87106, United States

Location

Valeant Site 26

New York, New York, 10022, United States

Location

Valeant Site 31

Stony Brook, New York, 11790, United States

Location

Valeant 05

Gresham, Oregon, 97030, United States

Location

Valeant Site 22

Fort Washington, Pennsylvania, 19034, United States

Location

Valeant Site 24

Charleston, South Carolina, 29414, United States

Location

Valeant Site 06

Dallas, Texas, 75231, United States

Location

Valeant Site 30

Houston, Texas, 77004, United States

Location

Valeant Site 17

Pflugerville, Texas, 78660, United States

Location

Valeant Site 07

San Antonio, Texas, 78229, United States

Location

Valeant 18

Webster, Texas, 77598, United States

Location

Valeant Site 29

Salt Lake City, Utah, 84117, United States

Location

Valeant Site 21

Norfolk, Virginia, 23502, 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: October 13, 2016
• Study Start: November 3, 2015
• Primary Completion: February 22, 2017
• Study Completion: February 22, 2017
• Last Updated: January 3, 2020
• Results First Posted: January 3, 2020

Record last verified: 2019-12

Locations

US (39)