Date: 2015-12-21
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: RXi Pharmaceuticals (USA - MA)
Product: Samcyprone™ (diphenylcyclopropenone gel)
Action
mechanism: Samcyprone™ is a proprietary gel formulation of diphenylcyclopropenone (DPCP), a small molecule that has been used since the late 1970’s to stimulate regrowth of hair in patients with alopecia areata. Recent publications have supported its use as an immunomodulator for the treatment of alopecia areata, warts and cutaneous metastases of malignant melanoma. It is noteworthy that the mechanism of action of Samcyprone™ is linked to DPCP’s ability to alter the expression of multiple genes and miRNAs involved in the immune response. RXi Pharmaceuticals' work with Samcyprone™ should allow the compan to discover specific targets for the potential treatment of immunological disorders that are relevant to the skin as well as various systemic diseases. This approach may result in the development of sd-rxRNA® or other drugs that are more potent and selective for various indications, including the treatment of alopecia areata, warts or cutaneous metastases of malignant melanoma.
Disease: cutaneous warts caused by human papillomaviruses
Therapeutic area: Dermatological diseases - Infectious diseases
Country: USA
Trial
details: Warts are benign epidermal tumors caused by human papillomaviruses (HPVs). The active pharmaceutical ingredient DPCP has been used for many years as a compounded formulation in acetone for the treatment of warts, alopecia areata and more recently, cutaneous metastatic melanoma lesions. An improved topical ointment formulation of DPCP called Samcyprone™ will be evaluated for the treatment of common warts. (NCT02640820 )
Latest
news: * On December 21, 2015, RXi Pharmaceuticals announced the initiation of a Phase 2 clinical trial in dermatology. The clinical study RXI-SCP-1502 will evaluate the safety and clinical activity of Samcyprone™ on the clearance of cutaneous warts. RXI-SCP-1502 is a multi-center, multi-dose trial conducted in subjects with at least one cutaneous, plantar or periungual wart present for at least four weeks. In this Phase 2 trial, subjects are first treated with a sensitization dose on the inner arm and on one preselected wart lesion. Once the sensitization response is confirmed, subjects will continue with weekly treatments for 10 weeks. Wart clearance will be evaluated based on Investigator's Global Assessment Score (IGAS) and wart measurements over time during the treatment period.
