A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302)

NCT ID: NCT03168334

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 801 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-11
• Study Completion Date: 2018-07-24

Brief Summary

This is a multi-center, 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.

Detailed Description

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123 Vehicle Lotion. To be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

IDP-123 Lotion

Tazarotene 0.045% Lotion

Group Type: EXPERIMENTAL

IDP-123 Lotion

Intervention Type: DRUG

Tazarotene 0.045% Lotion

IDP-123 Vehicle Lotion

Vehicle Lotion

Group Type: PLACEBO_COMPARATOR

IDP-123 Vehicle Lotion

Intervention Type: DRUG

Vehicle Lotion

Interventions

IDP-123 Lotion

Tazarotene 0.045% Lotion

Intervention Type: DRUG

IDP-123 Vehicle Lotion

Vehicle Lotion

Intervention Type: DRUG

Other Intervention Names

IDP-123; Vehicle

Eligibility Criteria

Inclusion Criteria

1. Male or female at least 9 years of age and older;

2. 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);

3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the baseline visit;

4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;

5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;

6. Subjects with two or fewer facial nodules

Exclusion Criteria

1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;

2. 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;

3. 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;

4. Subjects with a facial beard or mustache that could interfere with the study assessments;

5. Subjects with more than two (2) facial nodules;

6. Evidence or history of cosmetic-related acne

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anya Loncaric

Role: STUDY_DIRECTOR

Valeant Pharmaceuticals

Locations

Valeant Site 41

Mobile, Alabama, United States

Valeant Site 22

Rogers, Arkansas, United States

Valeant Site 34

Carlsbad, California, United States

Valeant Site 12

Fremont, California, United States

Valeant Site 06

San Diego, California, United States

Valeant Site 13

San Diego, California, United States

Valeant Site 31

San Diego, California, United States

Valeant Site 36

Santa Ana, California, United States

Valeant Site 25

Denver, Colorado, United States

Valeant Site 05

Boynton Beach, Florida, United States

Valeant Site 29

Clearwater, Florida, United States

Valeant Site 38

Jupiter, Florida, United States

Valeant Site 02

Miami, Florida, United States

Valeant Site 26

West Palm Beach, Florida, United States

Valeant Site 44

Snellville, Georgia, United States

Valeant Site 32

Louisville, Kentucky, United States

Valeant Site 19

Rockville, Maryland, United States

Valeant Site 08

Bay City, Michigan, United States

Valeant Site 30

Clarkston, Michigan, United States

Valeant Site 37

Clinton Township, Michigan, United States

Valeant Site 20

Fort Gratiot, Michigan, United States

Valeant Site 24

Fridley, Minnesota, United States

Valeant Site 03

Morristown, New Jersey, United States

Valeant Site 42

Albuquerque, New Mexico, United States

Valeant Site 10

New York, New York, United States

Valeant Site 43

Rochester, New York, United States

Valeant Site 33

Stony Brook, New York, United States

Valeant Site 11

Oklahoma City, Oklahoma, United States

Valeant Site 28

Broomall, Pennsylvania, United States

Valeant Site 16

Warwick, Rhode Island, United States

Valeant Site 18

Knoxville, Tennessee, United States

Valeant Site 14

Murfreesboro, Tennessee, United States

Valeant Site 23

College Station, Texas, United States

Valeant Site 07

Dallas, Texas, United States

Valeant Site 27

Pflugerville, Texas, United States

Valeant Site 04

San Antonio, Texas, United States

Valeant Site 39

Sugar Land, Texas, United States

Valeant Site 09

Layton, Utah, United States

Valeant Site 15

West Jordan, Utah, United States

Valeant Site 21

Charlottesville, Virginia, United States

Valeant Site 35

Walla Walla, Washington, United States

Valeant Site 01

Surrey, British Columbia, Canada

Valeant Site 45

Winnipeg, Manitoba, Canada

Valeant Site 40

Windsor, Ontario, Canada

Valeant Site 17

Saint-Jérôme, Quebec, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

V01-123A-302

Identifier Type: -

Identifier Source: org_study_id