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Safety and Efficacy Study of SHAPE Gel in Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SHAPE Gel
Sponsored by
TetraLogic Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of scalp alopecia areata and scalp hair loss due to alopecia areata for a minimum of six months and a maximum of two years.
  • Patients taking thyroid medication or hormonal therapy must be on a stable dose for 6 months and maintain such throughout the study.
  • Willingness to maintain same hair style, including shampoo and hair dye, throughout the study period.
  • Willingness to have a small micro dot tattoo placed to allow for photographic analysis of treatment and application of study medication.

Exclusion Criteria:

  • History of systemic or cutaneous malignancy and/or lymphoproliferative disease, other than patients with: up to 3 basal cell carcinoma; up to three well differentiated cutaneous squamous cell carcinoma; and/or cervical intraepithelial neoplasm (CIN), treated successfully with no evidence of disease, and treated for greater than 6 months prior to study entry.
  • Current actinic keratosis on the scalp and/or face
  • Nevi or cutaneous lesions thought suspicious for malignancy.
  • History of or current gastrointestinal, pulmonary, cardiovascular, genitourinary or hematological disease, CNS disorders, infectious disease or coagulation disorders that would preclude participation in and completion of study assessments.
  • Positive for hepatitis B surface antigen, HIV or hepatitis C.
  • Co-existent androgenetic alopecia: in males: Norwood-Hamilton stage IV, V or VI; in females: Ludwig stage II or III.
  • Unwillingness to discontinue use of non-breathable wigs, weaves or shaving of scalp throughout course of study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SHAPE Gel

    Arm Description

    1% SHAPE Gel applied twice daily for 12 weeks.

    Outcomes

    Primary Outcome Measures

    Response evaluated using modified Severity of Alopecia Tool (mSALT)
    Severity of Alopecia Tool (SALT) estimates percent scalp hair loss and percent regrowth of hair following intervention

    Secondary Outcome Measures

    Effects on quality of life using Subject Assessment of Hair Loss (SAHL)
    The SAHL compares baseline hair volume and hair density with end of treatment hair volume and density
    Effects on quality of life using Alopecia Areata Symptom Impact Scale (AASIS)
    AASIS rates the severity of alopecia areata symptoms and interference of alopecia areata with daily functioning
    Effects on quality of life using the Skindex-16
    Skindex-16 assesses how often symptoms or signs of alopecia areata have been bothersome
    Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
    Evaluation of safety and tolerability will be assessed through adverse events (AEs), vital signs, physical examination, assessment of local skin changes and changes in clinical laboratory parameters

    Full Information

    First Posted
    December 15, 2015
    Last Updated
    October 18, 2016
    Sponsor
    TetraLogic Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02636244
    Brief Title
    Safety and Efficacy Study of SHAPE Gel in Alopecia Areata
    Official Title
    A Multi-Center, Open-Label Phase 2 Study to Evaluate the Safety and Efficacy of SHAPE Gel, a Histone Deacetylase Inhibitor, in Patients With Alopecia Areata
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2017 (undefined)
    Primary Completion Date
    August 2017 (Anticipated)
    Study Completion Date
    January 2018 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy and safety of SHAPE Gel applied topically to adult patients with alopecia areata of the scalp.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alopecia Areata

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SHAPE Gel
    Arm Type
    Experimental
    Arm Description
    1% SHAPE Gel applied twice daily for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    SHAPE Gel
    Other Intervention Name(s)
    SHP-141
    Primary Outcome Measure Information:
    Title
    Response evaluated using modified Severity of Alopecia Tool (mSALT)
    Description
    Severity of Alopecia Tool (SALT) estimates percent scalp hair loss and percent regrowth of hair following intervention
    Time Frame
    Every 4 weeks; up to 24 weeks
    Secondary Outcome Measure Information:
    Title
    Effects on quality of life using Subject Assessment of Hair Loss (SAHL)
    Description
    The SAHL compares baseline hair volume and hair density with end of treatment hair volume and density
    Time Frame
    Every 4 weeks; up to 24 weeks
    Title
    Effects on quality of life using Alopecia Areata Symptom Impact Scale (AASIS)
    Description
    AASIS rates the severity of alopecia areata symptoms and interference of alopecia areata with daily functioning
    Time Frame
    Every 4 weeks; up to 24 weeks
    Title
    Effects on quality of life using the Skindex-16
    Description
    Skindex-16 assesses how often symptoms or signs of alopecia areata have been bothersome
    Time Frame
    Every 4 weeks; up to 24 weeks
    Title
    Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
    Description
    Evaluation of safety and tolerability will be assessed through adverse events (AEs), vital signs, physical examination, assessment of local skin changes and changes in clinical laboratory parameters
    Time Frame
    Every 4 weeks, up to 12 weeks
    Other Pre-specified Outcome Measures:
    Title
    Pharmacodynamic effect determined through assessment of lymphocyte subsets
    Description
    Measured by CD3, CD4 and CD8 lymphocytes in skin as well as by other assessments of immune modulation in the scalp
    Time Frame
    Up to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of scalp alopecia areata and scalp hair loss due to alopecia areata for a minimum of six months and a maximum of two years. Patients taking thyroid medication or hormonal therapy must be on a stable dose for 6 months and maintain such throughout the study. Willingness to maintain same hair style, including shampoo and hair dye, throughout the study period. Willingness to have a small micro dot tattoo placed to allow for photographic analysis of treatment and application of study medication. Exclusion Criteria: History of systemic or cutaneous malignancy and/or lymphoproliferative disease, other than patients with: up to 3 basal cell carcinoma; up to three well differentiated cutaneous squamous cell carcinoma; and/or cervical intraepithelial neoplasm (CIN), treated successfully with no evidence of disease, and treated for greater than 6 months prior to study entry. Current actinic keratosis on the scalp and/or face Nevi or cutaneous lesions thought suspicious for malignancy. History of or current gastrointestinal, pulmonary, cardiovascular, genitourinary or hematological disease, CNS disorders, infectious disease or coagulation disorders that would preclude participation in and completion of study assessments. Positive for hepatitis B surface antigen, HIV or hepatitis C. Co-existent androgenetic alopecia: in males: Norwood-Hamilton stage IV, V or VI; in females: Ludwig stage II or III. Unwillingness to discontinue use of non-breathable wigs, weaves or shaving of scalp throughout course of study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Judith Schnyder
    Phone
    610-889-9900
    Ext
    151
    Email
    jschnyder@tlog.com

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy Study of SHAPE Gel in Alopecia Areata

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