Molluscum ContagiosumPhase 2NCT03017846
Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum, Phase 2
A Phase 2 study testing Cantharidin in people with Molluscum Contagiosum, run by Steven R Cohen at 1 site in United States.
Trial summary
Cantharidin is cited in the dermatology and pediatric literature as a valuable treatment option. Treatment is often available in private practice offices, where a prescribing physician may offer a non-FDA approved treatment on an individualized basis. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Molluscum Contagiosum
- What is being tested?
- Cantharidin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 6 Sep 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of MC by the Principal Investigator.
- Maximum of 50 lesions on locations including the face, trunk, back, left or right arm, left or right leg, hands, feet, buttocks, and groin.
- Execution of Informed Consent and or assent forms
Who cannot join
- Patients with immunosuppression, including organ transplantation, HIV infection.
- Patients utilizing immunosuppressive agents (including oral corticosteroids) will be excluded except for patients using inhaled corticosteroids, such as those utilized for asthma or allergic rhinitis.
- Females who have reached menarche and are sexually active as well as pregnant patients will be excluded as the effects of this drug have not been evaluated in pregnancy.
- Patients who have greater than 50 MC lesions will also be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Cantharidin is cited in the dermatology and pediatric literature as a valuable treatment option. Treatment is often available in private practice offices, where a prescribing physician may offer a non-FDA approved treatment on an individualized basis. The situation is different in many hospital and academic settings, such as our own for example, where the formulary is defined through a FDA-approved indication. The absence of an indication precludes its addition to many hospital formularies, thus limiting the options available to a prescribing physician and denying patient access to a treatment offered in the private practice setting. An indication and formulary status require controlled clinical trials on the safety and efficacy of cantharidin in MC. The objective of this trial is to see if this commercially-viable cantharidin formulation has a comparable safety and efficacy profile as formulations previously studied under conditions which most closely match the what has been historically done in the clinic.
- Conditions
- Molluscum Contagiosum
- Being tested
- Cantharidin
- Medical subject headings
- Molluscum Contagiosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CantharidinDrug
Application of topical cantharidin
| Study group | Role | What they receive |
|---|---|---|
| Cantharidin Treatment | Experimental | Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks. Receives: Drug: Cantharidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Total Lesion Clearance
100% reduction in baseline lesion count
Measured: Assessed at each visit, until final visit on week 12
Secondary outcomes (3)
Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions
Measured: At study completion, up to 12 weeks
Change in the Total Children's Dermatology Life Quality Index Score
Change in the Total Children's Dermatology Life Quality Index (CDLQI) given Visit 1 prior to the first treatment and at the last study visit, up to 12 weeks. The CDLQI examines how the patient feels about the symptoms and treatment, as well as how it affects leisure, school, personal relationships, sleep, clothing choices. A total score is calculated.
The total score for the CDLQI scores range:
0-1 = no effect on child's life 2-6 = small effect 7-12 = moderate effect 13-18 = very large effect 19-30 = extremely large effect
Measured: Baseline (At beginning of study, before treatment) and end of study (at study completion, week 12 or at earlier visit if all lesions have cleared)
Number of Patients Achieving Complete Lesion Clearance Compared to Prior Study (NCT02665260)
Comparison of the number of subjects achieving complete lesion clearance at study completion (up to 12 weeks) to the same measure obtained in our previous study (NCT02665260)
Measured: At study completion, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startSep 2016
- Primary completion6 Sep 2017
- Study completion6 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Molluscum ContagiosumStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven R Cohen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steven R Cohen, Montefiore Medical Center
- Investigators
- Steven R Cohen, MD, MPH, Principal investigator, Albert Einstein College of Medicine Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017846
- Sponsor's protocol ID
- 16-10-195
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2017
- Last updated
- 30 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum, Phase 2
- ClinicalTrials.gov ID
- NCT03017846
- Acronym / sponsor ID
- 16-10-195
- Conditions
- Molluscum Contagiosum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Steven R CohenUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 6 Sep 2017 (actual)
- Study completion
- 6 Sep 2017 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Posted 30 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cantharidin is cited in the dermatology and pediatric literature as a valuable treatment option. Treatment is often available in private practice offices, where a prescribing physician may offer a non-FDA approved treatment on an individualized basis. The situation is different in many hospital and academic settings, such as our own for example, where the formulary is defined through a FDA-approved indication. The absence of an indication precludes its addition to many hospital formularies, thus limiting the options available to a prescribing physician and denying patient access to a treatment offered in the private practice setting. An indication and formulary status require controlled clinical trials on the safety and efficacy of cantharidin in MC. The objective of this trial is to see if this commercially-viable cantharidin formulation has a comparable safety and efficacy profile as formulations previously studied under conditions which most closely match the what has been historically done in the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cantharidin Treatment | Experimental | Drug: CantharidinSubjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of MC by the Principal Investigator.
- Maximum of 50 lesions on locations including the face, trunk, back, left or right arm, left or right leg, hands, feet, buttocks, and groin.
- Execution of Informed Consent and or assent forms
Key exclusion criteria (4 listed)
- Patients with immunosuppression, including organ transplantation, HIV infection.
- Patients utilizing immunosuppressive agents (including oral corticosteroids) will be excluded except for patients using inhaled corticosteroids, such as those utilized for asthma or allergic rhinitis.
- Females who have reached menarche and are sexually active as well as pregnant patients will be excluded as the effects of this drug have not been evaluated in pregnancy.
- Patients who have greater than 50 MC lesions will also be excluded from the study.
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 |
|---|---|---|
| CantharidinApplication of topical cantharidin | Drug | Cantharidin Treatment |
Primary outcome
Number of Participants With Total Lesion Clearance
Time frame: Assessed at each visit, until final visit on week 12
100% reduction in baseline lesion count
3 secondary outcomes
Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions
Time frame: At study completion, up to 12 weeks
Change in the Total Children's Dermatology Life Quality Index Score
Time frame: Baseline (At beginning of study, before treatment) and end of study (at study completion, week 12 or at earlier visit if all lesions have cleared)
Number of Patients Achieving Complete Lesion Clearance Compared to Prior Study (NCT02665260)
Time frame: At study completion, up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Steven R Cohen, MD, MPH principal investigator
Albert Einstein College of Medicine Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cantharidin in people with Molluscum Contagiosum, run by Steven R Cohen at 1 site 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 4 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: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 30 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Total Lesion Clearance (time frame: Assessed at each visit, until final visit on week 12). 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 30 Jan 2019.