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

Common Warts Clinical Trial

Official title:

A Prospective, Phase 2a Study to Evaluate the Effectiveness and Safety of DPCP Ointment (Samcyprone™) on the Clearance of Verruca Vulgaris (Common Warts) in Subjects Ages 18 - 65 Years

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02640820
• Other study ID #: RXI-SCP-1502
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 18, 2015
• Last updated: February 21, 2018
• Start date: December 2015
• Est. completion date: May 2018

Study information

• Verified date: February 2018
• Source: RXi Pharmaceuticals, Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 83
• Est. completion date: May 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Sensitizing DPCP Ointment
Sensitization
• Treatment DPCP Ointment
Treatment

Locations

Country	Name	City	State
United States	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana
United States	International Dermatology Research	Miami	Florida
United States	Mount Sinai - St. Luke's	New York	New York
United States	Summit Dermatology	Oakbrook Terrace	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
RXi Pharmaceuticals, Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 to 6 weeks
Primary	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.	11 to 20 weeks
Secondary	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	30 weeks
Secondary	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	2 days
Secondary	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	2 days
Secondary	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	2 days
Secondary	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	2 days
Secondary	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	2 days