Clinical trial NCT02640820: Evaluate the Effectiveness and Safety of DPCP Ointment (Samcyprone™) on the Clearance of Verruca Vulgaris (Common Warts)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Common Warts
HPV (Human Papillomavirus)
Periungual Warts
Plantar Warts
Keywords: HPV
Verruca Vulgaris
Lead sponsor: RXi Pharmaceuticals, Corp.
Sponsor class: INDUSTRY
First posted: 2015-12-29
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The effectiveness of Sensitizing DPCP Ointment in eliciting a sensitization response in healthy subjects with common warts by assessing the immunotherapeutic response
timeFrame: 4 to 6 weeks
measure: The effectiveness of Treatment DPCP Ointment will be measured by the Investigator's Global Assessment Score (IGAS)
timeFrame: 11 to 20 weeks
Secondary outcomes:
measure: 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
timeFrame: 30 weeks
measure: To evaluate Cmax by pharmacokinetics (PK) of DPCP in blood after topical administration of the Sensitizing DPCP Ointment in a subset of subjects
timeFrame: 2 days
measure: 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
timeFrame: 2 days
measure: 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
timeFrame: 2 days
measure: 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
timeFrame: 2 days
measure: 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
timeFrame: 2 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: International Dermatology Research
state: Florida
city: Oakbrook Terrace
country: United States
facility: Summit Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: New York
country: United States
facility: Mount Sinai - St. Luke's
state: New York
Study officials:
affiliation: RXi Pharmaceuticals
name: Pamela Pavco, PhD
role: STUDY_DIRECTOR
References: