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Trial record 63 of 164 for:    acne AND Vehicle

Efficacy and Safety of IDP-120 Gel 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: NCT03003247
Recruitment Status : Completed
First Posted : December 26, 2016
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief Summary:
Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: IDP-120 Gel Drug: IDP 120 Component A Gel Drug: IDP 120 Component B Gel Drug: IDP 120 Vehicle Gel Phase 2

Detailed Description:
A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 364 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, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
Actual Study Start Date : November 2015
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : September 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: IDP-120 Gel
IDP-120 Gel is a combination treatment
Drug: IDP-120 Gel
IDP-120 Gel is a combination product
Other Name: Component A + B

Active Comparator: IDP-120 Component A Gel
IDP-120 Monad Gel of Component A
Drug: IDP 120 Component A Gel
Monad of Component A
Other Name: Component A

Active Comparator: IDP-120 Component B Gel
IDP-120 Monad Gel of Component B
Drug: IDP 120 Component B Gel
Monad of Component B
Other Name: Component B

Placebo Comparator: IDP-120 Vehicle Gel
IDP-120 Vehicle Gel
Drug: IDP 120 Vehicle Gel
Vehicle
Other Name: Vehicle




Primary Outcome Measures :
  1. Percent of subjects achieving clear or almost clear on the Evaluator's Global Severity Score. [ Time Frame: 12 Weeks ]
    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

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • 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)
  • Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening visit, and a negative urine pregnancy test at baseline visit.
  • Subjects must be willing to comply with study instructions and return to the clinic for required visits. Subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.
  • If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the subject wears makeup they must agree to use non-comedogenic makeup.

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.
  • 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.

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): NCT03003247


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Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Anya Loncaric Valeant Pharmaceuticals

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT03003247     History of Changes
Other Study ID Numbers: V01-120A-201
First Posted: December 26, 2016    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases