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Trial record 4 of 5 for:    idp 123

Multi-center, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study in the Treatment of Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03168334
Recruitment Status : Active, not recruiting
First Posted : May 30, 2017
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

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 and IDP-123Vehicle Lotion.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: IDP-123 Lotion Drug: IDP-123 Vehicle Lotion Phase 3

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-123Vehicle 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 801 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-123 Lotion and IDP-123 Vehicle Lotion in the Treatment of Acne Vulgaris
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : April 26, 2018
Estimated Study Completion Date : July 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: IDP-123 Lotion
lotion
Drug: IDP-123 Lotion
lotion

Placebo Comparator: IDP-123 Vehicle Lotion
Vehicle
Drug: IDP-123 Vehicle Lotion
Vehicle




Primary Outcome Measures :
  1. Superiority in absolute change in mean inflammatory lesion counts [ Time Frame: Baseline to 12 Weeks ]
    Superiority in absolute change from Baseline to Week 12 in mean inflammatory lesion counts

  2. Percent of subjects who achieve at least a two-grade reduction from baseline in the Evaluator's Global Severity Score. [ Time Frame: Baseline to Week 12 ]
    Percent of subjects who achieve at least a two-grade reduction from baseline and are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score. Evaluations will be scored on a scale of 0-4, with 0 being clear and 4 being severe.



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Ages Eligible for Study:   9 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

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): NCT03168334


Locations
United States, California
Valeant Site 01
San Diego, California, United States, 22434
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Anya Loncaric Valeant Pharmaceuticals

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT03168334     History of Changes
Other Study ID Numbers: V01-123A-302
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases