Safety and Efficacy Study of SHAPE Gel in Alopecia Areata

Phase 2

• Conditions: Alopecia Areata
• Interventions: Drug: SHAPE Gel

• Registration Number: NCT02636244
• Lead Sponsor: TetraLogic Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-21
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-18
• Last Update Posted: 2016-10-20
• Study Start: 2017-02
• Primary Completion: 2017-08
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHAPE Gel	SHAPE Gel	1% SHAPE Gel applied twice daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Response evaluated using modified Severity of Alopecia Tool (mSALT)	Every 4 weeks; up to 24 weeks	Severity of Alopecia Tool (SALT) estimates percent scalp hair loss and percent regrowth of hair following intervention

Secondary Outcome Measures

Name	Time	Method
Effects on quality of life using Subject Assessment of Hair Loss (SAHL)	Every 4 weeks; up to 24 weeks	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)	Every 4 weeks; up to 24 weeks	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	Every 4 weeks; up to 24 weeks	Skindex-16 assesses how often symptoms or signs of alopecia areata have been bothersome
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)	Every 4 weeks, up to 12 weeks	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