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

NCT ID: NCT02640820

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-05-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sensitization Phase

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.

Group Type: EXPERIMENTAL

Sensitizing DPCP Ointment

Intervention Type: DRUG

Sensitization

Treatment Phase

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.

Group Type: EXPERIMENTAL

Treatment DPCP Ointment

Intervention Type: DRUG

Treatment

Interventions

Sensitizing DPCP Ointment

Sensitization

Intervention Type: DRUG

Treatment DPCP Ointment

Treatment

Intervention Type: DRUG

Other Intervention Names

Samcyprone™; Samcyprone™

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RXi Pharmaceuticals, Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamela Pavco, PhD

Role: STUDY_DIRECTOR

RXi Pharmaceuticals

Locations

International Dermatology Research

Miami, Florida, United States

Summit Dermatology

Oakbrook Terrace, Illinois, United States

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, United States

Mount Sinai - St. Luke's

New York, New York, United States

Countries

United States

Other Identifiers

RXI-SCP-1502

Identifier Type: -

Identifier Source: org_study_id