Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 56 of 234 for:    acne AND Percent

A Phase 3, Double-Blind 2 Arm 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: NCT03168321
Recruitment Status : Completed
First Posted : May 30, 2017
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 813 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 : June 29, 2017
Actual Primary Completion Date : March 16, 2018
Actual Study Completion Date : September 5, 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
Other Name: IDP-123

Placebo Comparator: IDP-123 Vehicle Lotion
Lotion
Drug: IDP-123 Vehicle Lotion
lotion
Other Name: Placebo




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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;

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): NCT03168321


  Show 45 Study Locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
Layout table for investigator information
Study Director: Anya Loncaric Valeant Pharmaceuticals

Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT03168321     History of Changes
Other Study ID Numbers: V01-123A-301
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases