Mechanism of Immune Modulation by DPCP in Alopecia Areata
This study aims to evaluate the response, safety, and efficacy of proprietary diphenylcyclopropenone (DPCP) gel in 39 patients and perform molecular profiling of defined T-cell subsets, associated cytokines and hair keratin mRNAs. Pilot data from this study will be used to re-submit for NIH funding of a larger and potentially multi-center clinical research trial.
Alopecia areata (AA) is a complex genetic, immune-mediated disease that targets anagen hair follicles. It can be a very challenging disease to treat particularly in those patients with extensive loss and in children, as there is currently no FDA approved therapy for AA. Topical immunotherapy has long been an accepted therapy for AA and application of diphenylcyclopropenone (DPCP) is recommended throughout the world. Topical DPCP is known to alter cytokine profiles providing the opportunity to use these profiles as potential biomarkers for therapeutic success. We postulate that optimizing DPCP immunotherapy could be safer, less costly and provide a more conservative treatment for alopecia areata than some of the emerging systemic therapies. This project will use a half-head topical treatment approach to determine the response, safety and efficacy of a proprietary DPCP gel for AA. Concurrent with the treatment protocol we will be able to match changes in cytokine profiles, keratin expression, and Cytomegalovirus UL16-Binding Protein (ULBP3) expression to hair re-growth during treatment. Response biomarkers of hair keratin mRNAs will permit more objective categorization of biological responses to DPCP versus change in inflammatory cytokines and regulatory molecules. Results of this study will provide unique insights into pathogenesis of AA and provide information that could stimulate new and more targeted treatment for AA in larger clinical trials.
If successful, this pilot trial in collaboration with the company formulating DPCP in a standardized format could lead to larger studies, a high return on investment from the NIH, and ultimately FDA approval of this commonly used off-label therapy. The results of molecular profiling could also produce fundamental insight and lead to new approaches in alopecia areata drug development.