Evaluate the Effectiveness and Safety of DPCP Ointment (Samcyprone™) on the Clearance of Verruca Vulgaris (Common Warts)
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
1 other identifier
interventional
83
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2015
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 18, 2015
CompletedFirst Posted
Study publicly available on registry
December 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedFebruary 23, 2018
February 1, 2018
2.1 years
December 18, 2015
February 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (6)
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
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
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
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
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
- +1 more secondary outcomes
Study Arms (2)
Sensitization Phase
EXPERIMENTALUp 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.
Treatment Phase
EXPERIMENTALIn 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
International Dermatology Research
Miami, Florida, 33144, United States
Summit Dermatology
Oakbrook Terrace, Illinois, 60181, United States
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256, United States
Mount Sinai - St. Luke's
New York, New York, 10029, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pamela Pavco, PhD
RXi Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2015
First Posted
December 29, 2015
Study Start
December 1, 2015
Primary Completion
January 1, 2018
Study Completion
May 1, 2018
Last Updated
February 23, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share