DPCP for the Treatment of Alopecia Areata
Alopecia Areata
About this trial
This is an interventional treatment trial for Alopecia Areata
Eligibility Criteria
Inclusion Criteria:
- Subject has clinical diagnosis of extensive alopecia areata (76%-99% involvement as determined by SALT score, Appendix B, Part I).
- Written informed consent and HIPAA authorization have been obtained.
- Subject is > 18 to years of age.
- Female subjects of childbearing potential have a negative pregnancy test and agree to use an acceptable, highly effective method of birth control (i.e., failure rate of less than 1% per year) to prevent pregnancy.
- Subject agrees to comply with protocol requirements and attend all required study visits and is considered to be a good study subject.
Subject meets concomitant medication washout requirements
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Exclusion Criteria:
- Subject has <76 or greater than 99% hair loss.
- Subject is pregnant or lactating.
- Subject has current controlled or uncontrolled bacterial, viral (with the exception of herpes simplex), fungal, atypical, or opportunistic infection(s).
- Subject has a history of substance abuse within the past five years.
- Immunosuppression (history of transplantation, chemotherapy, splenectomy, HIV).
- Administration of systemic treatment (e.g., Imuran, biologics) that have an immunomodulatory mechanism of action in the preceding 3 months.
- Previous treatment with DPCP.
- Application of topical immunomodulating agent in the preceding 6 weeks.
- Application of topical or intralesional corticosteroids within the past 6 weeks.
- Systemic (oral, inhaled, or intravenous) administration of corticosteroid or other systemic treatment (i.e., prednisone) with an immunosuppressive mechanism of action within the past 3 months.
- Use of light treatments (e.g., PUVA, narrow band UVB) in the preceding 6 weeks.
- Use of Anthralin in preceding 6 weeks.
- Use of minoxidil, topical or oral, in the preceding 4 weeks.
- Subject is currently or has undergone systemic therapy for malignancy within the past five years except for adequately treated Squamous Cell Carcinoma (SCC) or Basal Cell Carcinoma (BCC) of the skin.
- Clinical evidence of secondary skin infection (i.e., folliculitis).
- Participation in other therapeutic investigational clinical trials within 4 weeks of enrollment.
- Evidence of anemia, thyroid disease, sarcoidosis or other medical condition that could be adversely affected by participating in the study.
Subject has any medical condition that, in the judgment of the Investigator, would jeopardize the subject's safety following exposure to the administered medications.
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Sites / Locations
- University of Minnesota Department of DermatologyRecruiting
- University of Minnesota Department of DermatologyRecruiting
Arms of the Study
Arm 1
Other
Diphenylcyclopropenone (DPCP) Ointment
All subjects will be administered a sensitization dose of 0.05 mL 0.4% DPCP ointment formulation topically in the inner aspect of the upper right arm at Day -16, and 0.05 mL of four concentrations (0.1, .05, 0.01, 0.005%), prepared through dilutions in the ointment vehicle, topically on the inner aspect of the left thigh at Day -2. The weakest strength that may cause a minimal reaction (DTH skin reaction score of 1+) after two days will be chosen, and 0.75-1 g of that concentration will be applied to the scalp starting at Week 1 and administered subsequently twice a week for 18 weeks