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

Phase 2

• Conditions: Plantar Warts; HPV (Human Papillomavirus); Periungual Warts; Common Warts
• Interventions: Drug: Treatment DPCP Ointment; Drug: Sensitizing DPCP Ointment

• Registration Number: NCT02640820
• Lead Sponsor: RXi Pharmaceuticals, Corp.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-18
• Study First Submitted QC: 2015-12-28
• Study First Posted: 2015-12-29
• Primary Completion: 2018-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-23
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Phase	Treatment DPCP Ointment	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.
Sensitization Phase	Sensitizing DPCP Ointment	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.

Primary Outcome Measures

Name	Time	Method
The effectiveness of Sensitizing DPCP Ointment in eliciting a sensitization response in healthy subjects with common warts by assessing the immunotherapeutic response	4 to 6 weeks	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
The effectiveness of Treatment DPCP Ointment will be measured by the Investigator's Global Assessment Score (IGAS)	11 to 20 weeks	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.

Secondary Outcome Measures

Name	Time	Method
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	30 weeks	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
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	2 days	Determine Clast of Sensitizing DPCP Ointment in whole blood
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	2 days	Determine the time of Cmax of Sensitizing DPCP Ointment in whole blood
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	2 days	Determine Tlast of Sensitizing DPCP Ointment in whole blood
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	2 days	Determine the AUC of Sensitizing DPCP Ointment in whole blood
To evaluate Cmax by pharmacokinetics (PK) of DPCP in blood after topical administration of the Sensitizing DPCP Ointment in a subset of subjects	2 days	Determine Cmax of Sensitizing DPCP Ointment in whole blood

Trial Locations

Locations (4)

Dawes Fretzin Clinical Research Group; 🇺🇸 Indianapolis, Indiana, United States

Summit Dermatology; 🇺🇸 Oakbrook Terrace, Illinois, United States

International Dermatology Research; 🇺🇸 Miami, Florida, United States

Mount Sinai - St. Luke's; 🇺🇸 New York, New York, United States