Molluscum ContagiosumPhase 3CAMP-2NCT03377803
Cantharidin Application in Molluscum Patients
A Phase 3 study testing VP-102 - Cantharidin, Topical Film Forming Solution in people with Molluscum Contagiosum, run by Verrica Pharmaceuticals Inc. at 15 sites in United States.
Trial summary
This study is a Phase 3, randomized, double-blind, placebo-controlled, pivotal study to evaluate the safety and efficacy of VP-102 topical film-forming solution in subjects with Molluscum Contagiosum. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Molluscum Contagiosum
- What is being tested?
- VP-102 - Cantharidin, Topical Film Forming Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 15 sitesUnited States
- Study dates
- 14 Feb 2018to 26 Sep 2018
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- To qualify for inclusion in this study, subjects must:
- Be healthy subjects, at least 2 years of age or older.
- Consent to having all molluscum lesions treated and the physician must be willing to treat all molluscum lesions initially present. Lesions within 10mm of the eyelid margins or the margin of any mucosal membrane should be evaluated carefully to ensure that they can be safely treated. Non-mucosal genital area lesions and inflamed lesions are considered treatable.
- Be otherwise medically healthy with no clinically significant medical history as determined by the investigator. Subjects exhibiting active Atopic Dermatitis may be enrolled.
- On day of treatment refrain from application of all topical agents including alcohol-based sanitary products and sunscreens for a minimum of 4 hours before Study drug application. Topical agents including alcohol-based sanitary products and sunscreens may be used after application of the study drug so long as they are not applied within 5cm of treated skin lesions.
- Refrain from swimming, bathing or prolonged immersion in water or any liquids until the Study drug is removed.
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- Have the ability or have a guardian with the ability to follow study instructions and be likely to complete all study requirements.
- Provide written informed consent or assent in a manner approved by the institutional review board (IRB) and/or have a parent/guardian provide written informed consent as evidenced by the signature on an IRB approved assent/consent form.
- Provide written authorization for use and disclosure of protected health information.
- Agree to allow photographs to be taken, (selected sites only) of selected lesions at every visit that will be used for training, publication and future marketing brochures.
Who cannot join
- Subjects will be excluded from the study if they:
- Are unable to cooperate with the requirements or visits of the study, as determined by the investigator.
- Are systemically immunosuppressed or are receiving treatments such as chemotherapy or other non-topical immunosuppressive agents.
- Have any lesions present at baseline in anatomic locations that the subject/parent/guardian or the physician is unwilling to treat.
- Have had any previous treatment of molluscum including the use of cantharidin, antivirals, retinoids, curettage or freezing of lesions in the past 14 days. Additional treatments should not be implemented during the course of the study.
- Have a history of illness or any dermatologic disorder which, in the opinion of the investigator, will interfere with accurate counting of lesions or increase the risk of adverse events.
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- History or presence of clinically significant medical, psychiatric, or emotional condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the data.
- Have a history or presence of hypersensitivity or an idiosyncratic reaction to the Study drug or related compounds, or drug product excipients (acetone, ethyl alcohol, nitrocellulose, hydroxypropyl cellulose, castor oil, camphor, gentian violet, and denatonium benzoate).
- Have a condition or situation that may interfere significantly with the subject's participation in the study (e.g., subjects who required hospitalization in the 2 months prior to screening for an acute or chronic condition including alcohol or drug abuse), at the discretion of the investigator.
- Have received another investigational product within 14 days prior to the first application of the Study drug.
- Have been treated within 14 days with a product that contains cantharidin (topical or homeopathic preparations) for any reason prior to screening.
- Are sexually active or may become sexually active and are unwilling to practice responsible birth control methods. (e.g., combination of condoms and foam, birth control pills, intrauterine device, patch, shot and vaginal ring, etc.). Withdrawal is not an acceptable method of birth control. Females that have reached menarche must have a negative urine pregnancy test at each visit prior to treatment with Study drug.
- Are pregnant or breastfeeding.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Tekton Research
Austin, Texas, 78745
Bakersfield Dermatology
Bakersfield, California, 93309
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Dermatology Center of Northwestern Indiana
Crown Point, Indiana, 46307
Pedia Research
Evansville, Indiana, 47715
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Solution Through Advanced Research
Jacksonville, Florida, 32256
Midwest Children's Health-Northwoods
Lincoln, Nebraska, 68505
Midwest Children's Health
Lincoln, Nebraska, 68505
DCOL Center for Clinical Research
Longview, Texas, 75605
The Education and Research Foundation
Lynchburg, Virginia, 24501
Pedia Research
Owensboro, Kentucky, 42301
Rady Children's Hospital
San Diego, California, 92123
Redwood Family Dermatology
Santa Rosa, California, 95403
Lenus Research and Medical Group
Sweetwater, Florida, 33172
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Pivotal Study to Evaluate the Safety and Efficacy of VP-102 Topical Film-Forming Solution [0.7% (w/v) Cantharidin] in Subjects (2 Years and Older) With Molluscum Contagiosum
This study is a Phase 3, randomized, double-blind, placebo-controlled, pivotal study to evaluate the safety and efficacy of VP-102 topical film-forming solution in subjects with Molluscum Contagiosum. VP-102 will be applied once every 21 days for up to 4 applications, to treatable molluscum contagiosum (molluscum) lesions on subjects 2 years and older. Efficacy will be assessed as the proportion of subjects achieving complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit.
Read the detailed description
This is a Phase 3, multi-center, randomized, double-blind, placebo (vehicle)-controlled, pivotal study that will be conducted in the United States to determine the efficacy and safety of VP-102 following treatment of molluscum lesions for up to 4 treatments, every 21 days, with VP-102/placebo in 250 subjects. Subjects will receive active VP-102 or placebo in a 3:2 ratio. Study drug (VP-102 or placebo) will be supplied in single-use applicators.
The film-forming Study drug solution will be applied and left on the lesions for 24 hours before the subject and/or parents/guardian washes the lesions. Study drug may be removed prior to the 24-hour time point in the event treatment-emergent AEs are experienced.
Molluscum lesions will be treated without occlusion in all anatomic areas including the face, trunk, back, arms, legs, hands, feet, anogenital region and buttocks.
- Conditions
- Molluscum Contagiosum
- Being tested
- VP-102 - Cantharidin, Topical Film Forming Solution, Placebo -Topical Film Forming Solution without VP-102
- Keywords
- Molluscum, Skin Diseases, Poxviridae Infections, Skin Diseases; Infectious, Skin Diseases; Viral, DNA Poxvirus
- Medical subject headings
- Molluscum Contagiosum, Skin Diseases, Poxviridae Infections, Cellulitis, Skin Diseases, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VP-102 - Cantharidin, Topical Film Forming SolutionCombination product
VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Up to 4 applications of VP-102 will be administered to Molluscum lesions at 21-day intervals.
Placebo -Topical Film Forming Solution without VP-102Combination product
Placebo a single-use drug device combination product containing only the vehicle. Up to 4 applications of Placebo will be administered to Molluscum lesions at 21-day intervals.
| Study group | Role | What they receive |
|---|---|---|
| VP-102 | Active comparator | VP-102 is contained within a single-use applicator. The VP-102 applicator consists of a plastic tube containing a sealed glass ampule and an applicator tip. One ampule contains 450 μL of VP-102 (0.7% [w/v] cantharidin) solution. Receives: Combination Product: VP-102 - Cantharidin, Topical Film Forming Solution |
| Placebo | Placebo comparator | Placebo is contained within a single-use applicator. The placebo applicator consists of a plastic tube containing a sealed glass ampule and an applicator tip. One ampule contains 450μl of placebo solution with the same color and consistency as VP-102. Receives: Combination Product: Placebo -Topical Film Forming Solution without VP-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS)
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit (EOS).
Measured: Day 1 (Baseline) compared to Day 84 (EOS)
Secondary outcomes (3)
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 63 visit.
Measured: Day 1 (Baseline) compared to Day 63
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 42 visit.
Measured: Day 1 (Baseline) compared to Day 42
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 21 visit.
Measured: Day 1 (Baseline) compared to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start14 Feb 2018
- Primary completion26 Sep 2018
- Study completion26 Sep 2018
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.
- Publications (3)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verrica Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instat Consulting, Inc., Paidion Research, Inc., Database Integrations, Inc.
- Responsible party
- Sponsor
- Investigators
- Lawrence Eichenfield, MD, Principal investigator, Rady Children's Hospital; San Diego, California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377803
- Sponsor's protocol ID
- VP-102-102
- Acronym
- CAMP-2
- Status last verified
- Nov 2021
- First submitted
- 13 Dec 2017
- Last updated
- 14 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Eichenfield LF, Kwong P, Gonzalez ME, Yan A, D'Arnaud P, Burnett P, Olivadoti M. Safety and Efficacy of VP-102 (Cantharidin, 0.7% w/v) in Molluscum Contagiosum by Body Region: Post hoc Pooled Analyses from Two Phase III Randomized Trials. J Clin Aesthet Dermatol. 2021 Oct;14(10):42-47.
PubMed 34976290Eichenfield LF, Siegfried E, Kwong P, McBride M, Rieger J, Glover D, Willson C, Davidson M, Burnett P, Olivadoti M. Pooled Results of Two Randomized Phase III Trials Evaluating VP-102, a Drug-Device Combination Product Containing Cantharidin 0.7% (w/v) for the Treatment of Molluscum Contagiosum. Am J Clin Dermatol. 2021 Mar;22(2):257-265. doi: 10.1007/s40257-020-00570-8. Epub 2021 Feb 18.
PubMed 33599960Eichenfield LF, McFalda W, Brabec B, Siegfried E, Kwong P, McBride M, Rieger J, Willson C, Davidson M, Burnett P. Safety and Efficacy of VP-102, a Proprietary, Drug-Device Combination Product Containing Cantharidin, 0.7% (w/v), in Children and Adults With Molluscum Contagiosum: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2020 Dec 1;156(12):1315-1323. doi: 10.1001/jamadermatol.2020.3238.
PubMed 32965495
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Pivotal Study to Evaluate the Safety and Efficacy of VP-102 Topical Film-Forming Solution [0.7% (w/v) Cantharidin] in Subjects (2 Years and Older) With Molluscum Contagiosum
- ClinicalTrials.gov ID
- NCT03377803
- Acronym / sponsor ID
- CAMP-2 / VP-102-102
- Conditions
- Molluscum Contagiosum
- Keywords
- Molluscum, Skin Diseases, Poxviridae Infections, Skin Diseases; Infectious, Skin Diseases; Viral, DNA Poxvirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Verrica Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- Instat Consulting, Inc., Paidion Research, Inc., Database Integrations, Inc.
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Posted 14 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase 3, randomized, double-blind, placebo-controlled, pivotal study to evaluate the safety and efficacy of VP-102 topical film-forming solution in subjects with Molluscum Contagiosum. VP-102 will be applied once every 21 days for up to 4 applications, to treatable molluscum contagiosum (molluscum) lesions on subjects 2 years and older. Efficacy will be assessed as the proportion of subjects achieving complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit.
Detailed description
This is a Phase 3, multi-center, randomized, double-blind, placebo (vehicle)-controlled, pivotal study that will be conducted in the United States to determine the efficacy and safety of VP-102 following treatment of molluscum lesions for up to 4 treatments, every 21 days, with VP-102/placebo in 250 subjects. Subjects will receive active VP-102 or placebo in a 3:2 ratio. Study drug (VP-102 or placebo) will be supplied in single-use applicators.
The film-forming Study drug solution will be applied and left on the lesions for 24 hours before the subject and/or parents/guardian washes the lesions. Study drug may be removed prior to the 24-hour time point in the event treatment-emergent AEs are experienced.
Molluscum lesions will be treated without occlusion in all anatomic areas including the face, trunk, back, arms, legs, hands, feet, anogenital region and buttocks.
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 |
|---|---|---|
| VP-102 | Active comparator | Combination Product: VP-102 - Cantharidin, Topical Film Forming SolutionVP-102 is contained within a single-use applicator. The VP-102 applicator consists of a plastic tube containing a sealed glass ampule and an applicator tip. One ampule contains 450 μL of VP-102 (0.7% [w/v] cantharidin) solution. |
| Placebo | Placebo comparator | Combination Product: Placebo -Topical Film Forming Solution without VP-102Placebo is contained within a single-use applicator. The placebo applicator consists of a plastic tube containing a sealed glass ampule and an applicator tip. One ampule contains 450μl of placebo solution with the same color and consistency as VP-102. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Be healthy subjects, at least 2 years of age or older.
- Consent to having all molluscum lesions treated and the physician must be willing to treat all molluscum lesions initially present. Lesions within 10mm of the eyelid margins or the margin of any mucosal membrane should be evaluated carefully to ensure that they can be safely treated. Non-mucosal genital area lesions and inflamed lesions are considered treatable.
- Be otherwise medically healthy with no clinically significant medical history as determined by the investigator. Subjects exhibiting active Atopic Dermatitis may be enrolled.
- On day of treatment refrain from application of all topical agents including alcohol-based sanitary products and sunscreens for a minimum of 4 hours before Study drug application. Topical agents including alcohol-based sanitary products and sunscreens may be used after application of the study drug so long as they are not applied within 5cm of treated skin lesions.
- Refrain from swimming, bathing or prolonged immersion in water or any liquids until the Study drug is removed.
Key exclusion criteria (13 listed)
- Are unable to cooperate with the requirements or visits of the study, as determined by the investigator.
- Are systemically immunosuppressed or are receiving treatments such as chemotherapy or other non-topical immunosuppressive agents.
- Have any lesions present at baseline in anatomic locations that the subject/parent/guardian or the physician is unwilling to treat.
- Have had any previous treatment of molluscum including the use of cantharidin, antivirals, retinoids, curettage or freezing of lesions in the past 14 days. Additional treatments should not be implemented during the course of the study.
- Have a history of illness or any dermatologic disorder which, in the opinion of the investigator, will interfere with accurate counting of lesions or increase the risk of adverse events.
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 |
|---|---|---|
| VP-102 - Cantharidin, Topical Film Forming SolutionVP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Up to 4 applications of VP-102 will be administered to Molluscum lesions at 21-day intervals. | Combination product | VP-102 |
| Placebo -Topical Film Forming Solution without VP-102Placebo a single-use drug device combination product containing only the vehicle. Up to 4 applications of Placebo will be administered to Molluscum lesions at 21-day intervals. | Combination product | Placebo |
Primary outcome
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS)
Time frame: Day 1 (Baseline) compared to Day 84 (EOS)
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit (EOS).
3 secondary outcomes
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit
Time frame: Day 1 (Baseline) compared to Day 63
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit
Time frame: Day 1 (Baseline) compared to Day 42
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit
Time frame: Day 1 (Baseline) compared to Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34976290Eichenfield LF, Kwong P, Gonzalez ME, Yan A, D'Arnaud P, Burnett P, Olivadoti M. Safety and Efficacy of VP-102 (Cantharidin, 0.7% w/v) in Molluscum Contagiosum by Body Region: Post hoc Pooled Analyses from Two Phase III Randomized Trials. J Clin Aesthet Dermatol. 2021 Oct;14(10):42-47.
- Derived from this study: PubMed 33599960Eichenfield LF, Siegfried E, Kwong P, McBride M, Rieger J, Glover D, Willson C, Davidson M, Burnett P, Olivadoti M. Pooled Results of Two Randomized Phase III Trials Evaluating VP-102, a Drug-Device Combination Product Containing Cantharidin 0.7% (w/v) for the Treatment of Molluscum Contagiosum. Am J Clin Dermatol. 2021 Mar;22(2):257-265. doi: 10.1007/s40257-020-00570-8. Epub 2021 Feb 18.
- Derived from this study: PubMed 32965495Eichenfield LF, McFalda W, Brabec B, Siegfried E, Kwong P, McBride M, Rieger J, Willson C, Davidson M, Burnett P. Safety and Efficacy of VP-102, a Proprietary, Drug-Device Combination Product Containing Cantharidin, 0.7% (w/v), in Children and Adults With Molluscum Contagiosum: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2020 Dec 1;156(12):1315-1323. doi: 10.1001/jamadermatol.2020.3238.
- 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.
Lawrence Eichenfield, MD principal investigator
Rady Children's Hospital; San Diego, California
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VP-102 - Cantharidin, Topical Film Forming Solution in people with Molluscum Contagiosum, run by Verrica Pharmaceuticals Inc. at 15 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 10 inclusion and 13 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 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 14 Dec 2021). 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?
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS) (time frame: Day 1 (Baseline) compared to Day 84 (EOS)). 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 NCT03377803, which also lists 3 linked publications.
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 14 Dec 2021.