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.

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.