Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302)

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 : Completed
First Posted : May 30, 2017
Results First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Tracking Information
First Submitted Date  ICMJE May 24, 2017
First Posted Date  ICMJE May 30, 2017
Results First Submitted Date  ICMJE February 15, 2021
Results First Posted Date  ICMJE April 1, 2021
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE July 11, 2017
Actual Primary Completion Date July 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2021)
  • Absolute Change in Mean Lesion Counts at Week 12 [ Time Frame: Baseline to Week 12 ]
    For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
  • Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear" [ Time Frame: Baseline to Week 12 ]
    Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
  • 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
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2021)
  • Percentage Change in Mean Lesion Counts at Week 12 [ Time Frame: Baseline to Week 12 ]
    For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
  • Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) [ Time Frame: Baseline to Week 12 ]
    Evaluator's Global Severity Score (EGSS) was determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations were scored on a scale of 0-4, with 0 being clear and 4 being severe.
  • Percentage Change in Mean Lesion Counts at Week 8 [ Time Frame: Baseline to Week 8 ]
    For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) were counted and recorded separately.
  • Percentage Change in Mean Lesion Counts at Week 4 [ Time Frame: Baseline to Week 4 ]
    For noninflammatory facial lesions, open comedones (blackheads) and closed comedones (whiteheads) were recorded as a single count. For inflammatory facial lesions, papules (solid, elevated lesion less than 5 mm) and pustules (elevated lesion containing pus less than 5 mm) were recorded as a single count, while nodular lesions (palpable subcutaneous lesion greater than 5 mm) 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 A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302)
Official Title  ICMJE 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
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 in comparison with IDP-123 Vehicle Lotion.
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-123 Vehicle 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: IDP-123 Lotion
    Tazarotene 0.045% Lotion
    Other Name: IDP-123
  • Drug: IDP-123 Vehicle Lotion
    Vehicle Lotion
    Other Name: Vehicle
Study Arms  ICMJE
  • Experimental: IDP-123 Lotion
    Tazarotene 0.045% Lotion
    Intervention: Drug: IDP-123 Lotion
  • Placebo Comparator: IDP-123 Vehicle Lotion
    Vehicle Lotion
    Intervention: Drug: IDP-123 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 27, 2018)
801
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2017)
800
Actual Study Completion Date  ICMJE July 24, 2018
Actual Primary Completion Date July 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 99 Years   (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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03168334
Other Study ID Numbers  ICMJE V01-123A-302
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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 Director: Anya Loncaric Valeant Pharmaceuticals
PRS Account Bausch Health Americas, Inc.
Verification Date March 2021

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