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A Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
IDP-120 Gel
IDP-120 Component A
IDP-120 Component B
IDP-120 Vehicle Gel
Sponsored by
Valeant Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female at least 9 years of age and older
  • Written and verbal informed consent must be obtained.
  • Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment at the screening and baseline visit
  • Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening and baseline visits
  • Subjects must be willing to comply with study instructions and return to the clinic for required visits.

Exclusion Criteria:

  • Any dermatological conditions on the face that could interfere with clinical evaluations
  • 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
  • Subjects who are unable to communicate or cooperate with the Investigator
  • Subjects with any underlying disease that the Investigator deems uncontrolled and poses a concern for the subject's safety while participating in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    IDP-120 Gel

    IDP-120 Component A

    IDP-120 Component B

    IDP-120 Vehicle Gel

    Arm Description

    IDP-120 Gel, applied topically to the face once daily for 12 weeks.

    IDP-120 Component A, applied topically to the face once daily for 12 weeks

    IDP-120 Component B, applied topically to the face once daily for 12 weeks

    IDP-120 Vehicle Gel, applied topically to the face once daily for 12 weeks

    Outcomes

    Primary Outcome Measures

    Absolute change from Baseline to Week 12 in mean inflammatory lesion counts
    At each visit the Evaluator will count the total number of inflammatory lesions (papules, pustules, and nodules) on the subject's face. Inflammatory lesions are defined as follows: Papule - a small, solid elevation less than 5 mm in diameter. Most of the lesion is above the surface of the skin. Pustule - a small, circumscribed elevation less than 5 mm in diameter that contains yellow-white exudate. Nodule - a subcutaneous lesion greater than or equal to 5 mm in diameter.
    Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts
    At each visit the Evaluator will count the total number of non-inflammatory lesions (open and closed comedones). Non-inflammatory lesions are defined as follows: Open comedones (black head) - a lesion in which the follicle opening is widely dilated with the contents protruding out onto the surface of the skin. Closed comedones (white head)- a lesion in which the follicle opening is closed, but the sebaceous gland is enlarged by the pressure of the sebum build up, which in turn causes the skin around the follicle to thin and become elevated with a white appearance.
    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.
    At each visit the severity will be determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations will be scored on a scale of 0-4 (Evaluator's Global Severity Score), with 0 being clear and 4 being severe. Please see below for complete definitions. 0. Clear - Normal, clear skin with no evidence of acne vulgaris Almost clear- Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red) Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions) Moderate-Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one nodulo-cystic lesion Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulo-cystic lesions.

    Secondary Outcome Measures

    Absolute change in inflammatory and non-inflammatory lesion counts from baseline at Weeks 2, 4, and 8.
    At each visit the Evaluator will count the total number of inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the subject's face, and the change will be calculated.
    Percent of subjects who achieve at least a two-grade reduction from baseline and are Clear or Almost Clear at Week 2, 4, and 8 in the Evaluator's Global Severity Score
    At each visit the severity will be determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations will be scored on a scale of 0-4 (Evaluator's Global Severity Score), with 0 being clear and 4 being severe. Please see below for complete definitions. 0. Clear - Normal, clear skin with no evidence of acne vulgaris Almost clear- Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red) Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions) Moderate-Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one nodulo-cystic lesion Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulo-cystic lesions.
    Mean percent change in inflammatory and non-inflammatory lesion counts form baseline at Weeks 2, 4, 8, and 12.
    At each visit the Evaluator will count the total number of inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the subject's face, and the percent change will be calculated.

    Full Information

    First Posted
    August 28, 2015
    Last Updated
    September 11, 2015
    Sponsor
    Valeant Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02537483
    Brief Title
    A Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    September 2016 (Anticipated)
    Study Completion Date
    September 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Valeant Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary objective of this study is to compare the efficacy, safety, and tolerability of IDP-120 Gel to IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel in subjects with moderate to severe acne vulgaris.
    Detailed Description
    This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel in comparison with IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12 in subjects with moderate to severe acne. IDP-120 is a gel for the topical treatment of acne.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acne Vulgaris

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    350 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IDP-120 Gel
    Arm Type
    Experimental
    Arm Description
    IDP-120 Gel, applied topically to the face once daily for 12 weeks.
    Arm Title
    IDP-120 Component A
    Arm Type
    Active Comparator
    Arm Description
    IDP-120 Component A, applied topically to the face once daily for 12 weeks
    Arm Title
    IDP-120 Component B
    Arm Type
    Active Comparator
    Arm Description
    IDP-120 Component B, applied topically to the face once daily for 12 weeks
    Arm Title
    IDP-120 Vehicle Gel
    Arm Type
    Placebo Comparator
    Arm Description
    IDP-120 Vehicle Gel, applied topically to the face once daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    IDP-120 Gel
    Intervention Description
    Investigational Product: IDP-120 Gel
    Intervention Type
    Drug
    Intervention Name(s)
    IDP-120 Component A
    Intervention Description
    Comparator Product: IDP-120 Component A
    Intervention Type
    Drug
    Intervention Name(s)
    IDP-120 Component B
    Intervention Description
    Comparator Product: IDP-120 Component B
    Intervention Type
    Drug
    Intervention Name(s)
    IDP-120 Vehicle Gel
    Intervention Description
    Comparator Product: IDP-120 Vehicle Lotion
    Primary Outcome Measure Information:
    Title
    Absolute change from Baseline to Week 12 in mean inflammatory lesion counts
    Description
    At each visit the Evaluator will count the total number of inflammatory lesions (papules, pustules, and nodules) on the subject's face. Inflammatory lesions are defined as follows: Papule - a small, solid elevation less than 5 mm in diameter. Most of the lesion is above the surface of the skin. Pustule - a small, circumscribed elevation less than 5 mm in diameter that contains yellow-white exudate. Nodule - a subcutaneous lesion greater than or equal to 5 mm in diameter.
    Time Frame
    12 weeks
    Title
    Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts
    Description
    At each visit the Evaluator will count the total number of non-inflammatory lesions (open and closed comedones). Non-inflammatory lesions are defined as follows: Open comedones (black head) - a lesion in which the follicle opening is widely dilated with the contents protruding out onto the surface of the skin. Closed comedones (white head)- a lesion in which the follicle opening is closed, but the sebaceous gland is enlarged by the pressure of the sebum build up, which in turn causes the skin around the follicle to thin and become elevated with a white appearance.
    Time Frame
    12 weeks
    Title
    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.
    Description
    At each visit the severity will be determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations will be scored on a scale of 0-4 (Evaluator's Global Severity Score), with 0 being clear and 4 being severe. Please see below for complete definitions. 0. Clear - Normal, clear skin with no evidence of acne vulgaris Almost clear- Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red) Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions) Moderate-Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one nodulo-cystic lesion Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulo-cystic lesions.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Absolute change in inflammatory and non-inflammatory lesion counts from baseline at Weeks 2, 4, and 8.
    Description
    At each visit the Evaluator will count the total number of inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the subject's face, and the change will be calculated.
    Time Frame
    2, 4, and 8 weeks
    Title
    Percent of subjects who achieve at least a two-grade reduction from baseline and are Clear or Almost Clear at Week 2, 4, and 8 in the Evaluator's Global Severity Score
    Description
    At each visit the severity will be determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations will be scored on a scale of 0-4 (Evaluator's Global Severity Score), with 0 being clear and 4 being severe. Please see below for complete definitions. 0. Clear - Normal, clear skin with no evidence of acne vulgaris Almost clear- Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red) Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions) Moderate-Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one nodulo-cystic lesion Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulo-cystic lesions.
    Time Frame
    2, 4, and 8 weeks
    Title
    Mean percent change in inflammatory and non-inflammatory lesion counts form baseline at Weeks 2, 4, 8, and 12.
    Description
    At each visit the Evaluator will count the total number of inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the subject's face, and the percent change will be calculated.
    Time Frame
    2, 4, 8, and 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female at least 9 years of age and older Written and verbal informed consent must be obtained. Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment at the screening and baseline visit Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening and baseline visits Subjects must be willing to comply with study instructions and return to the clinic for required visits. Exclusion Criteria: Any dermatological conditions on the face that could interfere with clinical evaluations 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 Subjects who are unable to communicate or cooperate with the Investigator Subjects with any underlying disease that the Investigator deems uncontrolled and poses a concern for the subject's safety while participating in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anya Loncaric, MS
    Phone
    510-259-5284
    Email
    aloncaric@solta.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anya Loncaric, MS
    Organizational Affiliation
    Valeant Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

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