Safety and Efficacy Study of SHAPE Gel in Alopecia Areata

TetraLogic Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: SHAPE Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02636244

SHP-141-POC-0004-PTL

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

SHAPE Gel

Experimental group

Description:

1% SHAPE Gel applied twice daily for 12 weeks.

Treatment:

Drug: SHAPE Gel