Molluscum Contagiosum, Skin DiseaseNCT00667225

Efficacy of Cantharidin in Molluscum Contagiosum

A study testing Cantharidin 0.7% in people with Molluscum Contagiosum, Skin Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 5 to 10 years
Conditions the study is for: Molluscum Contagiosum, Skin Disease
What is being tested?: Cantharidin 0.7%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 29 participants
Where: 1 siteUnited States
Study dates: Jan 2008to Jun 2009
Phase: Interventional
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 5 to 10 years
All sexes
No healthy volunteers
Child

Who may be able to join

Anyone aged 5-10 years with the clinical diagnosis of molluscum contagiosum.

Who cannot join

Anyone with immunosuppression including HIV or previous organ transplantation.
Anyone taking immunosuppressive medications.
Anyone who has previously received treatment with cantharidin.
Any female who has had her first menstrual period.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina
Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

Official title: Efficacy of Cantharidin in Molluscum Contagiosum: A Randomized, Blinded, Placebo-Controlled Prospective Study

The University of North Carolina Department of Dermatology is conducting a clinical trial to evaluate a drug called cantharidin in the treatment of molluscum contagiosum. Molluscum is a common dermatologic disorder caused by a poxvirus. Molluscum typically presents with many flesh-colored bumps on the skin. It goes away on its own, though can last several months to several years. Cantharidin is a topical medicine which is applied at the clinic visit. It is well tolerated by the majority of children.

Conditions: Molluscum Contagiosum, Skin Disease
Being tested: cantharidin's vehicle, Cantharidin 0.7%
Medical subject headings: Molluscum Contagiosum, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cantharidin's vehicleDrug
Cantharidin's vehicle is composed of: Hydroxypropylcellulose, Acetone, and Collodion Flexible. The vehicle will be topically applied to molluscum lesions at each visit. Only two lesions will be treated at the first visit, and up to 20 lesions can be treated at subsequent visits.
Cantharidin 0.7%Drug
Subjects in this arm will receive cantharidin at all visits. At the first visit, up to 2 lesions can have application with cantharidin. All other visits will have up to 20 lesions with application of the cantharidin. During every visit, lesions will be counted and subjects will be assessed for any adverse events.

Study groups in NCT00667225
Study group	Role	What they receive
I	Placebo comparator	Subjects in this group will have topical application of cantharidin's vehicle at each visit. Receives: Drug: cantharidin's vehicle
II	Experimental	Subjects in this group will have topical application of cantharidin at each visit. Receives: Drug: Cantharidin 0.7%

What is being measured

The primary outcome is the main question the study is designed to answer.

Patients Experiencing Complete Clearance of All Molluscum Lesions.
Measured: Baseline compared to 8 weeks (5 visits)

Secondary outcomes (1)

Mean Change in Each Group Measured by Lesion Count.
Average change in number of lesions from baseline to 8 weeks
Measured: Baseline compared to 8 weeks (5 visits)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Jun 2009

First posted28 Apr 2008 (estimated)
Study startJan 2008
Primary completionJun 2009
Study completionJun 2009

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 Contagiosum, Skin DiseaseStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00667225
Sponsor's protocol ID: IRB 07-1330
Other IDs: RR000046
Status last verified: Jun 2011
First submitted: 24 Apr 2008
Last updated: 21 Jun 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Cantharidin in Molluscum Contagiosum: A Randomized, Blinded, Placebo-Controlled Prospective Study
ClinicalTrials.gov ID: NCT00667225
Acronym / sponsor ID: IRB 07-1330
Conditions: Molluscum Contagiosum, Skin Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Center for Research Resources (NCRR), Doris Duke Charitable Foundation
Study start: Jan 2008
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 28 Apr 2008 (estimated)
Results: Posted 1 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
I	Placebo comparator	Drug: cantharidin's vehicleSubjects in this group will have topical application of cantharidin's vehicle at each visit.
II	Experimental	Drug: Cantharidin 0.7%Subjects in this group will have topical application of cantharidin at each visit.

Who may qualify

Ages: 5 to 10 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Anyone aged 5-10 years with the clinical diagnosis of molluscum contagiosum.

Key exclusion criteria (4 listed)

Anyone with immunosuppression including HIV or previous organ transplantation.
Anyone taking immunosuppressive medications.
Anyone who has previously received treatment with cantharidin.
Any female who has had her first menstrual period.

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
cantharidin's vehicleCantharidin's vehicle is composed of: Hydroxypropylcellulose, Acetone, and Collodion Flexible. The vehicle will be topically applied to molluscum lesions at each visit. Only two lesions will be treated at the first visit, and up to 20 lesions can be treated at subsequent visits.	Drug	I
Cantharidin 0.7%Subjects in this arm will receive cantharidin at all visits. At the first visit, up to 2 lesions can have application with cantharidin. All other visits will have up to 20 lesions with application of the cantharidin. During every visit, lesions will be counted and subjects will be assessed for any adverse events.	Drug	II

Primary outcome

Patients Experiencing Complete Clearance of All Molluscum Lesions.
Time frame: Baseline compared to 8 weeks (5 visits)

1 secondary outcome

Mean Change in Each Group Measured by Lesion Count.
Time frame: Baseline compared to 8 weeks (5 visits)

Results and safety

Results posted to the registry on 1 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vehicle	16	15
Cantharidin	13	12

Primary outcome: Patients Experiencing Complete Clearance of All Molluscum Lesions.

Time frame: Baseline compared to 8 weeks (5 visits). Number. Unit: Participants

Measure	Vehicle n = 16	Cantharidin n = 13
Value	1	3

Population analysed: We used a power calculation to estimate the number of patients needed to detect a clinically significant result.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vehicle	0 of 16 (0%)	1 of 16 (6.3%)	Not reported
Cantharidin	0 of 13 (0%)	3 of 13 (23.1%)	Not reported

Limitations and caveats (from the sponsor): Small sample size and random disproportionate assignment to the vehicle group. Other limitations include short duration of follow up and interval between treatments. Finally, matching subjects in each group with comparable lesion counts.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Jacquelyn R Dosal, MD principal investigator

UNC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cantharidin 0.7% in people with Molluscum Contagiosum, Skin Disease, run by University of North Carolina, Chapel Hill 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 1 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 21 Jun 2011. 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. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2011). 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?

Patients Experiencing Complete Clearance of All Molluscum Lesions. (time frame: Baseline compared to 8 weeks (5 visits)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00667225.

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 21 Jun 2011.