Safety and Efficacy Study of SHAPE Gel in Alopecia Areata

• Status: Unknown status
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TetraLogic Pharmaceuticals
• Treatments: Histone Deacetylase Inhibitors

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.