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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cantharidin Treatment | Experimental | Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cantharidin | Drug | Application of topical cantharidin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Total Lesion Clearance | 100% reduction in baseline lesion count | Assessed at each visit, until final visit on week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions | 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 |
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Inclusion Criteria:
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
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Steven R Cohen, MD, MPH | Albert Einstein College of Medicine Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cantharidin Treatment | Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks. Cantharidin: Application of topical cantharidin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cantharidin Treatment | Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks. Cantharidin: Application of topical cantharidin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Total Lesion Clearance | 100% reduction in baseline lesion count | Posted | Count of Participants | Participants | Assessed at each visit, until final visit on week 12 |
|
|
Adverse event data was collected through study completion, up to 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cantharidin Treatment | Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks. Cantharidin: Application of topical cantharidin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Guzman, MD | Albert Einstein College of Medicine | 7189208352 | anguzman@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2017 | Sep 5, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008976 | Molluscum Contagiosum |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D002193 | Cantharidin |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 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) | At study completion, up to 12 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions | Posted | Count of Participants | Participants | At study completion, up to 12 weeks |
|
|
|
| Secondary | 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 | All patients who were not lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | At study completion, up to 12 weeks |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 28 |
| 30 |
| Tooth Fracture | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | Non-systematic Assessment |
|
| Pharyngitis Streptococcal | Infections and infestations | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Application Site Discoloration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Application Site Vesicles | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Excoriation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Impetigo | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash Erythematous | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash Papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Scab | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D017193 |
| Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |