Molluscum ContagiosumPhase 2NCT02665260
Safety and Efficacy Study of Topical Cantharidin for the Treatment of Molluscum Contagiosum
A Phase 2 study testing Cantharidin and Gauze occlusion bandage in people with Molluscum Contagiosum, run by Montefiore Medical Center.
Trial summary
The purpose of this study is to determine if cantharidin is a safe and effective treatment for molluscum contagiosum in kids Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Molluscum Contagiosum
- What is being tested?
- Cantharidin and Gauze occlusion bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Jan 2016
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- 2-17years
- Healthy
- <50 molluscum contagiosum lesions
Who cannot join
- Immunosuppressed
- Oral corticosteroids
- Sexually active/pregnant
About this study
Official title: Randomized Pilot Study Investigating the Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum
The purpose of this study is to determine if cantharidin is a safe and effective treatment for molluscum contagiosum in kids
Read the detailed description
This was a double-blind, placebo-controlled trial. Participants were recruited from the Pediatric Dermatology clinic at Montefiore Medical Center. One hundred eligible participants were randomly assigned to receive cantharidin 0.7% topical, cantharidin 0.7% topical with occlusion, placebo, or placebo with occlusion. Treatments were applied at weeks 0 and 3 (blinded phase). At week 6, all participants were treated with open-label, topical cantharidin 0.7% without occlusion every 3 weeks until all lesions resolved (open-label phase).
- Conditions
- Molluscum Contagiosum
- Being tested
- Cantharidin, Placebo, Gauze occlusion bandage
- 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
Also called 2,6-Dimethyl-4,10-dioxatricyclo-decane-3,5-dione
cantharidin 0.7% topical liquid
PlaceboDrug
Also called flexible collodion
Placebo topical liquid
Gauze occlusion bandageDevice
Gauze occlusion bandage with adhesive tape
| Study group | Role | What they receive |
|---|---|---|
| Cantharidin with occlusion | Active comparator | Cantharidin 0.7% topical with occlusion Receives: Drug: Cantharidin; Device: Gauze occlusion bandage |
| Cantharidin without occlusion | Experimental | Cantharidin 0.7% topical without occlusion Receives: Drug: Cantharidin |
| Placebo with occlusion | Placebo comparator | Placebo topical with occlusion Receives: Drug: Placebo; Device: Gauze occlusion bandage |
| Placebo without occlusion | Placebo comparator | Placebo topical without occlusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Achieve Complete Clearance at 6 Weeks
Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase)
Measured: 6 weeks
Secondary outcomes (1)
Number of Subjects Who Experienced an Adverse Event
Number of subjects who experienced an adverse event as assessed by patient-reported outcomes questionnaire at each visit
Measured: 33 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJul 2012
- Primary completionNov 2015
- Study completionJan 2016
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.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven R Cohen, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665260
- Sponsor's protocol ID
- 12-01-004
- Status last verified
- Mar 2017
- First submitted
- 31 Dec 2015
- Last updated
- 5 May 2017
- 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 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Study Investigating the Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum
- ClinicalTrials.gov ID
- NCT02665260
- Acronym / sponsor ID
- 12-01-004
- Conditions
- Molluscum Contagiosum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Posted 5 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if cantharidin is a safe and effective treatment for molluscum contagiosum in kids
Detailed description
This was a double-blind, placebo-controlled trial. Participants were recruited from the Pediatric Dermatology clinic at Montefiore Medical Center. One hundred eligible participants were randomly assigned to receive cantharidin 0.7% topical, cantharidin 0.7% topical with occlusion, placebo, or placebo with occlusion. Treatments were applied at weeks 0 and 3 (blinded phase). At week 6, all participants were treated with open-label, topical cantharidin 0.7% without occlusion every 3 weeks until all lesions resolved (open-label phase).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cantharidin with occlusion | Active comparator | Drug: Cantharidin, Device: Gauze occlusion bandageCantharidin 0.7% topical with occlusion |
| Cantharidin without occlusion | Experimental | Drug: CantharidinCantharidin 0.7% topical without occlusion |
| Placebo with occlusion | Placebo comparator | Drug: Placebo, Device: Gauze occlusion bandagePlacebo topical with occlusion |
| Placebo without occlusion | Placebo comparator | Drug: PlaceboPlacebo topical without occlusion |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 2-17years
- Healthy
- <50 molluscum contagiosum lesions
Key exclusion criteria (3 listed)
- Immunosuppressed
- Oral corticosteroids
- Sexually active/pregnant
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 |
|---|---|---|
| CantharidinAlso: 2,6-Dimethyl-4,10-dioxatricyclo-decane-3,5-dionecantharidin 0.7% topical liquid | Drug | Cantharidin with occlusion, Cantharidin without occlusion |
| PlaceboAlso: flexible collodionPlacebo topical liquid | Drug | Placebo with occlusion, Placebo without occlusion |
| Gauze occlusion bandageGauze occlusion bandage with adhesive tape | Device | Cantharidin with occlusion, Placebo with occlusion |
Primary outcome
Number of Subjects Who Achieve Complete Clearance at 6 Weeks
Time frame: 6 weeks
Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase)
1 secondary outcome
Number of Subjects Who Experienced an Adverse Event
Time frame: 33 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cantharidin and Gauze occlusion bandage in people with Molluscum Contagiosum, run by Montefiore Medical Center.
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: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 5 May 2017). 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 Subjects Who Achieve Complete Clearance at 6 Weeks (time frame: 6 weeks). 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 5 May 2017.