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Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
IDP-123 Lotion
Tazorac Cream, 0.1%,
Vehicle Cream
Vehicle Lotion
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

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

Inclusion Criteria:

  • Male or female at least 12 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
  • Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the 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 subjects 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

    Placebo Comparator

    Placebo Comparator

    Arm Label

    IDP-123 Lotion

    Tazorac Cream, 0.1%

    Vehicle Cream

    Vehicle Lotion

    Arm Description

    IDP-123 Lotion, applied topically to the face, once daily for 12 weeks.

    Tazorac Cream (tazarotene 0.1%), applied topically to the face, once daily for 12 weeks.

    Vehicle Cream, applied topically to the face, once daily for 12 weeks.

    Vehicle Lotion, applied topically to the face, once daily for 12 weeks.

    Outcomes

    Primary Outcome Measures

    Absolute change in mean inflammatory lesion counts at Week 12
    Facial area lesion counts will be taken from the subject's face by the Evaluator at each visit and the change at week 12 from baseline will be calculated. Facial inflammatory lesions (pustules, papules, and nodules) will be counted as follows: pustules and papules will be counted and recorded together, not separately; nodular lesions will be counted and recorded separately. Inflammatory lesions are defined as follows: Papule - a solid, elevated lesion less than 5 mm; Pustule - an elevated lesion containing pus less than 5 mm; Nodule - palpable subcutaneous lesion greater than 5 mm; has depth, not necessarily elevated
    Absolute change in mean non-inflammatory lesion counts at Week 12
    Facial area lesion counts will be taken from the subject's face by the Evaluator at each visit, and the change at week 12 from baseline will be calculated. Non-inflammatory lesions (open and closed comedones) will be counted and recorded together. Non-inflammatory lesions are defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface
    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 Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulocystic 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 nodulocystic lesion Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulocystic lesions.

    Secondary Outcome Measures

    Mean percent change in inflammatory lesion count from baseline at Weeks 2, 4, 8, and 12.
    At each visit the Evaluator will count the total number of inflammatory lesions (papules, pustules, and nodules) on the subject's face, and the percent change will be calculated.
    Mean percent change in non-inflammatory lesion counts from baseline at Weeks 2, 4, 8 and 12.
    At each visit the Evaluator will count the total number of non-inflammatory lesions (open and closed comedones), and the percent change will be calculated.
    The proportion of subjects with at least a two grade improvement in the Evaluator's Global Severity Score from baseline at Weeks 2, 4, 8 and 12.
    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 nodulocystic 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 nodulocystic lesion Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulocystic lesions.

    Full Information

    First Posted
    August 13, 2015
    Last Updated
    September 11, 2015
    Sponsor
    Valeant Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02525822
    Brief Title
    Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris
    Official Title
    A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac® (Tazarotene) Cream, 0.1%, 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
    September 2015 (undefined)
    Primary Completion Date
    June 2016 (Anticipated)
    Study Completion Date
    June 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 safety and efficacy of once daily application of IDP-123 Lotion to Tazorac Cream, 0.1%, Vehicle Lotion, and Vehicle Cream 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-123 Lotion in comparison with Tazorac Cream, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne. Treatment success will be evaluated by changes in inflammatory and non-inflammatory lesion counts, as well as treatment success using an Evaluator's Global Severity Score. IDP-123 is a lotion 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 ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    210 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IDP-123 Lotion
    Arm Type
    Experimental
    Arm Description
    IDP-123 Lotion, applied topically to the face, once daily for 12 weeks.
    Arm Title
    Tazorac Cream, 0.1%
    Arm Type
    Active Comparator
    Arm Description
    Tazorac Cream (tazarotene 0.1%), applied topically to the face, once daily for 12 weeks.
    Arm Title
    Vehicle Cream
    Arm Type
    Placebo Comparator
    Arm Description
    Vehicle Cream, applied topically to the face, once daily for 12 weeks.
    Arm Title
    Vehicle Lotion
    Arm Type
    Placebo Comparator
    Arm Description
    Vehicle Lotion, applied topically to the face, once daily for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    IDP-123 Lotion
    Intervention Description
    Investigational Product: IDP-123 Lotion
    Intervention Type
    Drug
    Intervention Name(s)
    Tazorac Cream, 0.1%,
    Other Intervention Name(s)
    tazarotene
    Intervention Description
    Comparator Product: Tazorac Cream, 0.1%
    Intervention Type
    Drug
    Intervention Name(s)
    Vehicle Cream
    Intervention Description
    Comparator Product: Vehicle Cream
    Intervention Type
    Drug
    Intervention Name(s)
    Vehicle Lotion
    Intervention Description
    Comparator Product: Vehicle Lotion
    Primary Outcome Measure Information:
    Title
    Absolute change in mean inflammatory lesion counts at Week 12
    Description
    Facial area lesion counts will be taken from the subject's face by the Evaluator at each visit and the change at week 12 from baseline will be calculated. Facial inflammatory lesions (pustules, papules, and nodules) will be counted as follows: pustules and papules will be counted and recorded together, not separately; nodular lesions will be counted and recorded separately. Inflammatory lesions are defined as follows: Papule - a solid, elevated lesion less than 5 mm; Pustule - an elevated lesion containing pus less than 5 mm; Nodule - palpable subcutaneous lesion greater than 5 mm; has depth, not necessarily elevated
    Time Frame
    12 weeks
    Title
    Absolute change in mean non-inflammatory lesion counts at Week 12
    Description
    Facial area lesion counts will be taken from the subject's face by the Evaluator at each visit, and the change at week 12 from baseline will be calculated. Non-inflammatory lesions (open and closed comedones) will be counted and recorded together. Non-inflammatory lesions are defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface
    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 Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulocystic 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 nodulocystic lesion Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulocystic lesions.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Mean percent change in inflammatory lesion count from baseline at Weeks 2, 4, 8, and 12.
    Description
    At each visit the Evaluator will count the total number of inflammatory lesions (papules, pustules, and nodules) on the subject's face, and the percent change will be calculated.
    Time Frame
    2, 4, 8, and 12 weeks
    Title
    Mean percent change in non-inflammatory lesion counts from baseline at Weeks 2, 4, 8 and 12.
    Description
    At each visit the Evaluator will count the total number of non-inflammatory lesions (open and closed comedones), and the percent change will be calculated.
    Time Frame
    2, 4, 8, and 12 weeks
    Title
    The proportion of subjects with at least a two grade improvement in the Evaluator's Global Severity Score from baseline at Weeks 2, 4, 8 and 12.
    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 nodulocystic 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 nodulocystic lesion Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulocystic lesions.
    Time Frame
    2, 4, 8, and 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female at least 12 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 Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the 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 subjects 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

    Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris

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