A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)

NCT03168321 | Completed Phase 3 Results FDA Drug

• 1 other identifier: V01-123A-301
• Study Type: interventional
• Target: 813
• Locations: 2 countries
• Sites: 45

Brief Summary

This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle Lotion.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Absolute Change in Mean Lesion Counts at Week 12

  For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.

  Baseline to Week 12

• Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear"

  Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.

  Baseline to Week 12

Secondary Outcomes (4)

• Percentage Change in Mean Lesion Counts at Week 12

  Baseline to Week 12

• Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS)

  Baseline to Week 12

• Percentage Change in Mean Lesion Counts at Week 8

  Baseline to Week 8

• Percentage Change in Mean Lesion Counts at Week 4

  Baseline to Week 4

Study Arms (2)

IDP-123 Lotion

EXPERIMENTAL

Tazarotene 0.045% Lotion

Drug: IDP-123 Lotion

IDP-123 Vehicle Lotion

PLACEBO COMPARATOR

Vehicle Lotion

Drug: IDP-123 Vehicle Lotion

Interventions

IDP-123 Lotion DRUG

Tazarotene 0.045% Lotion

Also known as: IDP-123

IDP-123 Lotion

IDP-123 Vehicle Lotion DRUG

Vehicle Lotion

Also known as: Vehicle

IDP-123 Vehicle Lotion

Eligibility Criteria

• Age: 9 Years - 99 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. 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);
• Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the baseline visit;
• Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;
• Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;
• Subjects with two or fewer nodules

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, dermatitis, eczema;
• 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;
• Subjects with more than two (2) facial nodules;
• Evidence or history of cosmetic-related acne

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (45)

Valeant Site 19

Phoenix, Arizona, 85032, United States

Location

Valeant Site 21

Phoenix, Arizona, 85032, United States

Location

Valeant Site 24

Hot Springs, Arkansas, 71913, United States

Location

Valeant Site 04

La Mesa, California, 91942, United States

Location

Valeant Site 02

Manhattan Beach, California, 90266, United States

Location

Valeant Site 42

Murrieta, California, 92562, United States

Location

Valeant Site 39

Sacramento, California, 95819, United States

Location

Valeant Site 01

San Diego, California, 22434, United States

Location

Valeant Site 37

Wheat Ridge, Colorado, 80033, United States

Location

Valeant Site 35

Boca Raton, Florida, 33486, United States

Location

Valeant Site 40

North Miami Beach, Florida, 33162, United States

Location

Valeant Site 33

Ormond Beach, Florida, 32174, United States

Location

Valeant Site 27

Pembroke Pines, Florida, 33028, United States

Location

Valeant Site 13

Sanford, Florida, 32771, United States

Location

Valeant Site 03

West Palm Beach, Florida, 33401, United States

Location

Valeant Site 26

Newnan, Georgia, 30263, United States

Location

Valeant Site 30

Boise, Idaho, 83704, United States

Location

Valeant Site 06

Arlington Heights, Illinois, 60005, United States

Location

Valeant Site 23

New Albany, Indiana, 47150, United States

Location

Valeant Site 17

South Bend, Indiana, 46617, United States

Location

Valeant Site 31

Overland Park, Kansas, 66215, United States

Location

Valeant Site 22

Louisville, Kentucky, 40217, United States

Location

Valeant Site 08

Metairie, Louisiana, 70006, United States

Location

Valeant Site 38

Detroit, Michigan, 48202, United States

Location

Valeant Site 16

Warren, Michigan, 48088, United States

Location

Valeant site 20

New York, New York, 10022, United States

Location

Valeant Site 36

New York, New York, 10075, United States

Location

Valeant Site 09

High Point, North Carolina, 27262, United States

Location

Valeant Site 32

Cincinnati, Ohio, 45236, United States

Location

Valeant Site 11

Dublin, Ohio, 43016, United States

Location

valeant Site 07

Gresham, Oregon, 97030, United States

Location

Valeant Site 15

Johnston, Rhode Island, 02919, United States

Location

Valeant Site 34

Knoxville, Tennessee, 37917, United States

Location

valeant Site 14

Nashville, Tennessee, 37215, United States

Location

Valeant Site 12

Austin, Texas, 78759, United States

Location

Valeant Site 05

Katy, Texas, 77494, United States

Location

Valeant Site 18

Plano, Texas, 75093, United States

Location

Valeant Site 25

San Antonio, Texas, 78213, United States

Location

Valeant Site 43

Webster, Texas, 77598, United States

Location

Valeant Site 41

Salt Lake City, Utah, 84114, United States

Location

Valeant Site 45

Norfolk, Virginia, 23507, United States

Location

Valeant Site 44

Spokane, Washington, 99202, United States

Location

Valeant Site 29

Peterborough, Ontario, K9J5K2, Canada

Location

Valeant Site 28

Waterloo, Ontario, N2J1C4, Canada

Location

Valeant Site 10

Laval, Quebec, H7E0E3, Canada

Location

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: Study Director
• Organization: Bausch Health Americas, Inc

aloncaric@bauschhealth.com

510-259-5284

Study Officials

• Anya Loncaric

  Valeant Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: June 29, 2017
• Primary Completion: June 7, 2018
• Study Completion: June 7, 2018
• Last Updated: April 1, 2021
• Results First Posted: April 1, 2021

Record last verified: 2021-03

Locations

US (42); CA (3)