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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.

Tracking Information
First Submitted Date  ICMJE May 6, 2016
First Posted Date  ICMJE December 26, 2016
Last Update Posted Date December 18, 2017
Actual Study Start Date  ICMJE November 2015
Actual Primary Completion Date August 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03003247 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
Official Title  ICMJE 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
Brief Summary Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: IDP-120 Gel
    IDP-120 Gel is a combination product
    Other Name: Component A + B
  • Drug: IDP 120 Component A Gel
    Monad of Component A
    Other Name: Component A
  • Drug: IDP 120 Component B Gel
    Monad of Component B
    Other Name: Component B
  • Drug: IDP 120 Vehicle Gel
    Vehicle
    Other Name: Vehicle
Study Arms  ICMJE
  • Experimental: IDP-120 Gel
    IDP-120 Gel is a combination treatment
    Intervention: Drug: IDP-120 Gel
  • Active Comparator: IDP-120 Component A Gel
    IDP-120 Monad Gel of Component A
    Intervention: Drug: IDP 120 Component A Gel
  • Active Comparator: IDP-120 Component B Gel
    IDP-120 Monad Gel of Component B
    Intervention: Drug: IDP 120 Component B Gel
  • Placebo Comparator: IDP-120 Vehicle Gel
    IDP-120 Vehicle Gel
    Intervention: Drug: IDP 120 Vehicle Gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2016)
364
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 30, 2016
Actual Primary Completion Date August 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03003247
Other Study ID Numbers  ICMJE V01-120A-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Bausch Health Americas, Inc.
Study Sponsor  ICMJE Bausch Health Americas, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Anya Loncaric Valeant Pharmaceuticals
PRS Account Bausch Health Americas, Inc.
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP