Evaluate the Effectiveness and Safety of DPCP Ointment (Samcyprone™) on the Clearance of Verruca Vulgaris (Common Warts)

RXi Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Plantar Warts; HPV (Human Papillomavirus); Common Warts; Periungual Warts

Treatments: Drug: Sensitizing DPCP Ointment; Drug: Treatment DPCP Ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02640820

RXI-SCP-1502

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects between the ages of 18 and 65 years of age, inclusive
• Subjects presenting with at least one verruca vulgaris (common cutaneous, plantar, and periungual) warts for at least 4 weeks, but no more than 3 years
• Subject's common warts for treatment must measure between 3 and 20 mm and be located on hands, feet, limbs and/or trunk. A maximum of four (4) cutaneous single warts or one (1) area of clustered or adjacent warts up to 80 mm will be treated

Exclusion criteria

• Genital warts may not be selected as target warts
• Subjects that are immuno-compromised
• Presence of systemic or localized diseases, conditions, or medications that could interfere with assessment of safety and efficacy or that compromise immune function

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

Sensitization Phase

Experimental group

Description:

Up to two doses of Sensitizing DPCP Ointment will be applied and subjects who exhibit a sensitization response will enter the Treatment Phase. Pharmacokinetics (PK) of Sensitizing DPCP Ointment will be measured in a subset of subjects. For PK, blood will be collected prior to application of the Sensitizing DPCP Ointment and again at 1, 2, and 24 hours after application.

Treatment:

Drug: Sensitizing DPCP Ointment

Treatment Phase

Experimental group

Description:

In the Treatment Phase, subjects will receive doses of Treatment DPCP Ointment weekly for 10 weeks. Subjects who at the end of the Treatment Phase have exhibited partial clearance of warts may be given the option to continue with an additional 10 weekly treatments.

Treatment:

Drug: Treatment DPCP Ointment