Safety and Efficacy Study of SHAPE Gel in Alopecia Areata

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: SHAPE Gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHAPE Gel<br>1% SHAPE Gel applied twice daily for 12 weeks. | Drug: SHAPE Gel<br> <br> * Other names: SHP-141;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Every 4 weeks; up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Every 4 weeks; up to 24 weeks | 
| 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 | Every 4 weeks; up to 24 weeks | 
| Effects on quality of life using the Skindex-16 | Skindex-16 assesses how often symptoms or signs of alopecia areata have been bothersome | Every 4 weeks; up to 24 weeks | 
| 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 | Every 4 weeks, up to 12 weeks |