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Safety and Efficacy of IDP-123 Lotion to Tazorac® Cream, in the Treatment of Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02938494
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

Brief Summary:
Safety and Efficacy of IDP-123 Lotion to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: IDP-123 Lotion Drug: Tazorac Cream Drug: Vehicle Lotion Drug: Vehicle Cream Phase 2

Detailed Description:
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac® (Tazarotene) Cream, in the Treatment of Acne Vulgaris
Study Start Date : November 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Tazarotene

Arm Intervention/treatment
Experimental: IDP-123 Lotion
Lotion
Drug: IDP-123 Lotion
Lotion
Other Name: Lotion

Active Comparator: Tazorac Cream
Cream
Drug: Tazorac Cream
Cream
Other Name: Tazorac

Active Comparator: Vehicle Lotion
Lotion
Drug: Vehicle Lotion
Lotion
Other Name: Vehicle

Active Comparator: Vehicle Cream
Cream
Drug: Vehicle Cream
Cream
Other Name: Vehicle




Primary Outcome Measures :
  1. Absolute change from Baseline to Week 12 in mean inflammatory lesion counts [ Time Frame: 12 weeks for all subjects. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male or female at least 12 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).
  • Women of childbearing potential and females that are pre-menses must be willing to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, IUD, condom with spermicidal, diaphragm with spermicidal, implant, Nuvaring, injection, transdermal patch or abstinence.) Females on birth control pills must have taken the same type pill for at least three months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least three months prior to the start of the study. Women who use birth control for acne control only should be excluded.
  • Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits.

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, gramnegative 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.
  • Evidence or history of cosmetic-related acne.
  • Subject has a history of experiencing significant burning or stinging when applying any facial treatment (eg, make-up, soap, masks, washes, sunscreens, etc) to their face.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938494


Locations
United States, California
Valeant Site 03
Encinitas, California, United States, 92024
Valeant Site 04
Fremont, California, United States, 94538
Valeant Site 06
Los Angeles, California, United States, 90036
Valeant Site 14
Sacramento, California, United States, 95819
Valeant Site 01
Santa Monica, California, United States, 90404
United States, Colorado
Valeant Site 05
Colorado Springs, Colorado, United States, 80915
United States, Florida
Valeant Site 08
Coral Gables, Florida, United States, 33146
Valeant Site 10
Miami, Florida, United States, 33175
Valeant Site 09
Miramar, Florida, United States, 33027
United States, Kentucky
Valeant Site 12
Louisville, Kentucky, United States, 40202
Valeant Site 13
Louisville, Kentucky, United States, 40217
United States, Maryland
Valeant Site 02
Rockville, Maryland, United States, 20850
United States, Minnesota
Valeant Site 07
Fridley, Minnesota, United States, 55432
United States, North Carolina
Valeant Site 16
Chapel Hill, North Carolina, United States, 27517
Valeant Site 15
High Point, North Carolina, United States, 27262
United States, Pennsylvania
Valeant Site 11
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Anya Loncaric Valeant Pharmaceuticals

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT02938494     History of Changes
Other Study ID Numbers: V01-123A-201
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Tazarotene
Nicotinic Acids
Dermatologic Agents
Keratolytic Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs