DPCP for the Treatment of Alopecia Areata

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open labeled study to determine the response and characteristics, safety and efficacy, of the proprietary DPCP ointment composition as a topical immunotherapeutic agent for the treatment of extensive alopecia areata.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: National Alopecia Areata Foundation

Criteria

Inclusion Criteria:

1. Subject has clinical diagnosis of extensive alopecia areata (76%-99% involvement as determined by SALT score, Appendix B, Part I).

2. Written informed consent and HIPAA authorization have been obtained.

3. Subject is > 18 to years of age.

4. 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.

5. Subject agrees to comply with protocol requirements and attend all required study visits and is considered to be a good study subject.

6. Subject meets concomitant medication washout requirements

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Exclusion Criteria:

1. Subject has <76 or greater than 99% hair loss.

2. Subject is pregnant or lactating.

3. Subject has current controlled or uncontrolled bacterial, viral (with the exception of herpes simplex), fungal, atypical, or opportunistic infection(s).

4. Subject has a history of substance abuse within the past five years.

5. Immunosuppression (history of transplantation, chemotherapy, splenectomy, HIV).

6. Administration of systemic treatment (e.g., Imuran, biologics) that have an immunomodulatory mechanism of action in the preceding 3 months.

7. Previous treatment with DPCP.

8. Application of topical immunomodulating agent in the preceding 6 weeks.

9. Application of topical or intralesional corticosteroids within the past 6 weeks.

10. 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.

11. Use of light treatments (e.g., PUVA, narrow band UVB) in the preceding 6 weeks.

12. Use of Anthralin in preceding 6 weeks.

13. Use of minoxidil, topical or oral, in the preceding 4 weeks.

14. 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.

15. Clinical evidence of secondary skin infection (i.e., folliculitis).

16. Participation in other therapeutic investigational clinical trials within 4 weeks of enrollment.

17. Evidence of anemia, thyroid disease, sarcoidosis or other medical condition that could be adversely affected by participating in the study.

18. 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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