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Trial record 8 of 11 for:    RXi

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

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ClinicalTrials.gov Identifier: NCT02640820
Recruitment Status : Active, not recruiting
First Posted : December 29, 2015
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Common Warts HPV (Human Papillomavirus) Periungual Warts Plantar Warts Drug: Sensitizing DPCP Ointment Drug: Treatment DPCP Ointment Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2015
Actual Primary Completion Date : January 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arm Intervention/treatment
Experimental: Sensitization Phase
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.
Drug: Sensitizing DPCP Ointment
Sensitization
Other Name: Samcyprone™

Experimental: Treatment Phase
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.
Drug: Treatment DPCP Ointment
Treatment
Other Name: Samcyprone™




Primary Outcome Measures :
  1. The effectiveness of Sensitizing DPCP Ointment in eliciting a sensitization response in healthy subjects with common warts by assessing the immunotherapeutic response [ Time Frame: 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

  2. The effectiveness of Treatment DPCP Ointment will be measured by the Investigator's Global Assessment Score (IGAS) [ Time Frame: 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 :
  1. 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 [ Time Frame: 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

  2. To evaluate Cmax by pharmacokinetics (PK) of DPCP in blood after topical administration of the Sensitizing DPCP Ointment in a subset of subjects [ Time Frame: 2 days ]
    Determine Cmax of Sensitizing DPCP Ointment in whole blood

  3. 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 [ Time Frame: 2 days ]
    Determine the time of Cmax of Sensitizing DPCP Ointment in whole blood

  4. 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 [ Time Frame: 2 days ]
    Determine Tlast of Sensitizing DPCP Ointment in whole blood

  5. 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 [ Time Frame: 2 days ]
    Determine Clast of Sensitizing DPCP Ointment in whole blood

  6. 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 [ Time Frame: 2 days ]
    Determine the AUC of Sensitizing DPCP Ointment in whole blood



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02640820


Locations
United States, Florida
International Dermatology Research
Miami, Florida, United States, 33144
United States, Illinois
Summit Dermatology
Oakbrook Terrace, Illinois, United States, 60181
United States, Indiana
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, United States, 46256
United States, New York
Mount Sinai - St. Luke's
New York, New York, United States, 10029
Sponsors and Collaborators
RXi Pharmaceuticals, Corp.
Investigators
Study Director: Pamela Pavco, PhD RXi Pharmaceuticals

Responsible Party: RXi Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier: NCT02640820     History of Changes
Other Study ID Numbers: RXI-SCP-1502
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by RXi Pharmaceuticals, Corp.:
HPV
Verruca Vulgaris

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases