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Trial record 3 of 166 for:    acne AND Vehicle

Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion 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: NCT02965456
Recruitment Status : Completed
First Posted : November 16, 2016
Results First Posted : December 18, 2019
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Tracking Information
First Submitted Date  ICMJE October 11, 2016
First Posted Date  ICMJE November 16, 2016
Results First Submitted Date  ICMJE December 2, 2019
Results First Posted Date  ICMJE December 18, 2019
Last Update Posted Date December 18, 2019
Actual Study Start Date  ICMJE November 4, 2015
Actual Primary Completion Date February 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2019)
  • Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12 [ Time Frame: Baseline (Day 0), Week 12 ]
    Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
  • Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12 [ Time Frame: Baseline, Week 12 ]
    Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.
  • Percentage of Participants With Treatment Success at Week 12 [ Time Frame: Baseline, Week 12 ]
    Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Original Primary Outcome Measures  ICMJE
 (submitted: November 11, 2016)
Percent of Subjects who achieve at least a two grade reduction from baseline and are Clear -or almost clear at week 12 in the evaluators Global Severity Score [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT02965456 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2019)
  • Percent Change From Baseline in Noninflammatory Lesion Count to Week 12 [ Time Frame: Baseline, Week 12 ]
    Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.
  • Percent Change From Baseline in Inflammatory Lesion Count to Week 12 [ Time Frame: Baseline, Week 12 ]
    Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.
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-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
Official Title  ICMJE A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
Brief Summary The objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an Evaluator's Global Severity Score [EGSS] of 3 [moderate] or 4 [severe]).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne
Intervention  ICMJE
  • Drug: IDP 121 Lotion
    IDP-121 lotion will be applied as per the instructions provided by the investigational center staff.
  • Drug: IDP-121 Vehicle Lotion
    IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff.
Study Arms  ICMJE
  • Experimental: IDP-121 Lotion
    IDP-121 lotion (tretinoin 0.05 percent [%]) will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
    Intervention: Drug: IDP 121 Lotion
  • Placebo Comparator: IDP-121 Vehicle Lotion
    IDP-121 lotion vehicle will be applied topically to the face of participants with moderate to severe acne, once daily for 12 weeks.
    Intervention: Drug: IDP-121 Vehicle Lotion
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: April 26, 2017)
820
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2016)
800
Actual Study Completion Date  ICMJE February 23, 2017
Actual Primary Completion Date February 23, 2017   (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. Participants 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 participant reaches age of consent during the study they should be re-consented at the next study visit).
  • Participants must be willing to comply with study instructions and return to the study center for required visits. Participants 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, participants must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the participant 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.
  • Participants with a facial beard or mustache that could interfere with the study assessments.
  • History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure, including known sensitivities to any dosage form of tretinoin.
  • Participants who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.
  • Participants with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the participant's safety while participating in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02965456
Other Study ID Numbers  ICMJE V01-121A-302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Bausch Health Americas, Inc.
Study Sponsor  ICMJE Bausch Health Americas, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Tim Theisen TKL Research, Inc.
PRS Account Bausch Health Americas, Inc.
Verification Date December 2019

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