DPCP for the Treatment of Alopecia Areata

Alopecia Areata Clinical Trial

Official title: An Open-Label Study to Evaluate DPCP Ointment for the Treatment of Alopecia Areata

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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.

Up to 10 subjects with 76% to 99% scalp hair loss that, in the opinion of the PI, are eligible for treatment with DPCP will be enrolled. Patients will be recruited from the new and current patient population seen for alopecia areata through the University of Minnesota Medical Center Dermatology Clinic as well as through partnership with the National Alopecia Areata Foundation Clinical Trials Network, and various media outlets.

The products to be evaluated are as follows:

• 0.05 mL of 0.4% DPCP (sensitization dose) applied topically to the inner aspect of the upper right arm. ("Sensitization and Baseline Sample Collection Visit")

• 0.05 mL four dose concentration matrix of DPCP ointment (0.1, 0.05, 0.01, 0.005%) prepared through dilutions in a non-volatile vehicle (applied to the inner aspect of the left upper thigh). ("Dose Determination Visit"; 10-14 days after the Sensitization Visit)If sensitization is not attained after 10 to 14 days, the procedure will be repeated once.

The subject will return 2 days after the Dose Determination Visit, so the PI or co-PI can assess the dose concentration matrix. The weakest strength concentration that caused a minimal reaction will be used throughout the study. 0.75-1 g of the treatment drug will be aThe treatment drug will be applied by the PI, a trained study coordinator, or a staff member of the Clinical Research Unit at the University of Minnesota. Eligible subjects may begin receiving the study drug immediately after enrollment and screening.

The estimated duration of the study is 22 weeks. See Appendix A for the schedule of visits. There will be a total of 42 visits, beginning with a screening visit followed by a single sensitizing dose of study drug at baseline (Day -16) and a dose determination application at Day -2.

Subjects will undergo twice weekly (+/- 2 days) topical applications of an ointment formulation of DPCP during Weeks 1-18. Application will be done twice per week. The drug application will be performed by a board certified dermatologist for the first two treatment visits (Days 0 and 3; Visits 4 and 5), after which a trained member of the Clinical Research Unit staff will apply the drug twice each week (Weeks 2-18; Visits 6-39). The investigator will attend one treatment visit in the Clinical Research Unit each month to evaluate the extent of hair loss and hair growth (Weeks 4, 8, 12, and 16).

Scalp biopsy specimen collection will be performed at baseline (Day -16, Visit 2), three days after the first treatment (i.e., challenge) application (Day 2, Visit 5), three days after the final application (Week 18 +3d, Visit 39) or during treatment when the study subject is determined to have achieved >=50% hair regrowth.

Three scalp biopsy samples will be collected by a board certified dermatologist. When possible, each sample will be taken from a balding area near an area with hair preferably in a non-androgen dependent site of the scalp. One of the three samples will be frozen in OCT for histologic examination and immunohistochemical studies. A second biopsy sample from an adjacent area will be placed in 10% buffered formalin for histologic examination and assessment of inflammation and hair follicle differentiation. The third sample from each area will immediately be placed in RNAlater (Qiagen, Valencia, CA) for cytokine expression analyses.

Peripheral blood collection for the study will include whole blood for serum and obtaining peripheral blood mononuclear cells (PBMCs). All blood samples will be transported to the Dermatology laboratory at the University of Minnesota for immediate processing and storage for additional biomarker studies.

Research coordinators will be involved in patient recruitment, contact, and scheduling. The PI and research coordinators will all be involved in the collection, analysis, and reporting of collected data.

applied in a thin film that covers the entire scalp. ;

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

• NCT number: NCT03651752
• Study type: Interventional
• Source: University of Minnesota
• Contact: Irmina Wallander, BA
• Phone: 6126245721
• Email: wall0396@umn.edu
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2024
• Completion date: September 1, 2024