Common WartsPhase 2NCT02640820
Evaluate the Effectiveness and Safety of DPCP Ointment (Samcyprone™) on the Clearance of Verruca Vulgaris (Common Warts)
A Phase 2 study testing Sensitizing DPCP Ointment and Treatment DPCP Ointment in people with Common Warts and HPV (Human Papillomavirus), run by RXi Pharmaceuticals, Corp. at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Common Warts, HPV (Human Papillomavirus), Periungual Warts
- What is being tested?
- Sensitizing DPCP Ointment and Treatment DPCP Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2015to May 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256
International Dermatology Research
Miami, Florida, 33144
Mount Sinai - St. Luke's
New York, New York, 10029
Summit Dermatology
Oakbrook Terrace, Illinois, 60181
About this study
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
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.
- Being tested
- Sensitizing DPCP Ointment, Treatment DPCP Ointment
- Keywords
- HPV, Verruca Vulgaris
- Medical subject headings
- Warts, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensitizing DPCP OintmentDrug
Also called Samcyprone™
Sensitization
Treatment DPCP OintmentDrug
Also called Samcyprone™
Treatment
| Study group | Role | What they receive |
|---|---|---|
| Sensitization Phase | Experimental | 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. Receives: Drug: Sensitizing DPCP Ointment |
| Treatment Phase | Experimental | 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. Receives: Drug: Treatment DPCP Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
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
Measured: 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
Determine Cmax of Sensitizing DPCP Ointment in whole blood
Measured: 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
Determine the time of Cmax of Sensitizing DPCP Ointment in whole blood
Measured: 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
Determine Tlast of Sensitizing DPCP Ointment in whole blood
Measured: 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
Determine Clast of Sensitizing DPCP Ointment in whole blood
Measured: 2 days
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
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2018
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- RXi Pharmaceuticals, Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela Pavco, PhD, Study director, RXi Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640820
- Sponsor's protocol ID
- RXI-SCP-1502
- Status last verified
- Feb 2018
- First submitted
- 18 Dec 2015
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02640820
- Acronym / sponsor ID
- RXI-SCP-1502
- Keywords
- HPV, Verruca Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (actual)
- Lead sponsor
- RXi Pharmaceuticals, Corp.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- May 2018 (estimated)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensitization Phase | Experimental | Drug: Sensitizing DPCP OintmentUp 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 | Experimental | Drug: Treatment DPCP OintmentIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensitizing DPCP OintmentAlso: Samcyprone™Sensitization | Drug | Sensitization Phase |
| Treatment DPCP OintmentAlso: Samcyprone™Treatment | Drug | Treatment Phase |
Primary outcome
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
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.
6 secondary outcomes
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Pavco, PhD study director
RXi Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sensitizing DPCP Ointment and Treatment DPCP Ointment in people with Common Warts and HPV (Human Papillomavirus), run by RXi Pharmaceuticals, Corp. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.