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

RXi Pharmaceuticals, Corp.83 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Common Warts HPV (Human Papillomavirus)Periungual Warts Plantar Warts

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

The effectiveness of Sensitizing DPCP Ointment in eliciting a sensitization response in healthy subjects with common warts by assessing the immunotherapeutic response

Assessment of immunotherapeutic response per subject will include gauging the Delayed-Type Hypersensitivity (DTH) response after application sensitizing DPCP ointment. A minimum +2 DTH response will be considered a positive sensitization result

Time frame: 4 to 6 weeks

The effectiveness of Treatment DPCP Ointment will be measured by the Investigator's Global Assessment Score (IGAS)

The Investigator's Global Assessment Score (IGAS) is a 4-point scale that will be used to evaluate wart clearance for all treated warts separately. Results will further be utilized to determine overall clearance of treated warts in total. Wart lesion surface area will be measured and used to assist in determining IGAS Score.

Time frame: 11 to 20 weeks

Secondary Outcomes

The safety and tolerability of a treatment regimen for common warts consisting of a sensitization dose with Sensitizing DPCP Ointment and ten weekly treatments with Treatment DPCP Ointment, assessed by reported adverse events

Reported adverse events and clinically-relevant changes in laboratory testing after treatment will be monitored for severity and frequency; incidence of Treatment-Emergent Adverse Events will be assessed

Time frame: 30 weeks

To evaluate Cmax by pharmacokinetics (PK) of DPCP in blood after topical administration of the Sensitizing DPCP Ointment in a subset of subjects

Determine Cmax of Sensitizing DPCP Ointment in whole blood

Time frame: 2 days

To evaluate the time to Cmax by pharmacokinetics (PK) of DPCP in blood after topical administration of the Sensitizing DPCP Ointment in a subset of subjects

Determine the time of Cmax of Sensitizing DPCP Ointment in whole blood

Time frame: 2 days

To evaluate the time to last measurable concentration (Tlast) by pharmacokinetics (PK) of DPCP in blood after topical administration of the Sensitizing DPCP Ointment in a subset of subjects

Determine Tlast of Sensitizing DPCP Ointment in whole blood

Time frame: 2 days

To evaluate the concentration corresponding to Tlast (Clast) by pharmacokinetics (PK) of DPCP in blood after topical administration of the Sensitizing DPCP Ointment in a subset of subjects

Determine Clast of Sensitizing DPCP Ointment in whole blood

Time frame: 2 days

To evaluate the area under the concentration curve (AUC) by pharmacokinetics (PK) of DPCP in blood after topical administration of the Sensitizing DPCP Ointment in a subset of subjects

Determine the AUC of Sensitizing DPCP Ointment in whole blood

Time frame: 2 days