Evaluation of Systemic Exposure to VP-102 in Subjects With Molluscum Contagiosum.

NCT03186378 | Completed Phase 2 Results DMC FDA Drug FDA Device

• 1 other identifier: VP-102-103
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to determine the presence or absence of systemic cantharidin exposure from a single 24-hour dermal application of VP-102 topical film-forming solution \[0.7% (w/v) cantharidin\] (VP-102) when applied to molluscum contagiosum (molluscum) lesions on pediatric subjects 2 years old and older. Treatment will continue over the course of 3 additional 21 day intervals allowing for further evaluation of safety, efficacy and impact on quality of life.

Conditions

Molluscum Contagiosum

Outcome Measures

Primary Outcomes (1)

• The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102.

  The primary objective is to determine any potential systemic exposure from a single 24-hour dermal application of VP-102 topical film-forming solution when applied to molluscum contagiosum (molluscum) lesions on pediatric subjects 2 years old and older.

  24 hours

Secondary Outcomes (1)

• Measurement of Efficacy - Complete Clearance

  Baseline through EOS Day 84

Other Outcomes (5)

• Proportion of Subjects Exhibiting a 90% or Greater Reduction of All Treated Molluscum Lesions (Baseline and New) at the EOS Visit.

  Baseline to EOS Day 84

• Percent Reduction of Treated Molluscum Lesions From Baseline at the EOS Visit.

  Baseline to EOS Day 84

• Change From Baseline in the Number of Treated Molluscum Lesions at the EOS Visit.

  Baseline to EOS Day 84

Study Arms (2)

Exposure Group

EXPERIMENTAL

This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator.

Combination Product: VP-102 with applicator

Standard Group

EXPERIMENTAL

This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator.

Combination Product: VP-102 with applicator

Interventions

VP-102 with applicator COMBINATION_PRODUCT

Subjects will receive treatment to their molluscum contagiosum with VP-102.

Exposure Group; Standard Group

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Be healthy subjects ages 2 years and older.
• Patients with 1-20 lesions may be enrolled and treated in the standard treatment group but are not eligible for the exposure study.
• Patients with 21 or more lesions may only be enrolled in the exposure group. Subjects participating in the Exposure group must have at least 21 lesions treated at Day 1 to qualify.
• Be otherwise medically healthy with no clinically significant medical history as determined by the investigator. Patients exhibiting active Atopic Dermatitis may be enrolled.
• 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 to or near treated skin.
• Refrain from swimming, bathing or prolonged immersion in water until the Study drug is removed.
• Have the ability or have a guardian able to follow study instructions and be likely to complete all study requirements.
• Provide assent in a manner approved by the institutional review board (IRB) and have a parent/guardian provide written informed consent as evidenced by signature on IRB approved assent/consent forms.
• Provide written authorization for use and disclosure of protected health information.
• Agree to allow photographs of all selected lesions to be taken and/or send photos via text or email to the study team for assessment at 24 hours post treatment. Photos may be used as part of the study data and/or marketing package. (Photographs will be de-identified to those outside the research team. Effort will be made to ensure that no photos with identifiable features are obtained).

You may not qualify if:

• Are unable to cooperate with the requirements or visits of the study, as determined by the investigator.
• Have molluscum venereum (sexually transmitted molluscum).
• Have active molluscum eczema.
• Are systemically immunosuppressed or are receiving treatments such as chemotherapy or other non-topical immunosuppressive agents.
• Have had any previous treatment of molluscum in the past 14 days including the use of cantharidin, antivirals, retinoids, curettage or freezing of lesions. Additional treatments for molluscum should not be implemented during the course of the study.
• Have 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.
• 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.
• Have a condition or situation that may interfere significantly with the subject's participation in the study (e.g., patients 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 the active ingredient in VP-102 (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. Females that have reached menarche, must have a negative urine pregnancy test at screening and each visit prior to treatment with study medication.
• Are pregnant or breastfeeding.

Sponsors & Collaborators

• Verrica Pharmaceuticals Inc.: lead
• Paidion Research, Inc.: collaborator
• Database Integrations, Inc.: collaborator
• Cato Research: collaborator
• Instat Services: collaborator

Study Sites (1)

Midwest Children's Health

Lincoln, Nebraska, 68522, United States

Location

Related Publications (1)

• Niazi S, Brabec B, Anschutz L, Willson C, Davidson M, Burnett P. A Phase 2 Open-Label Study to Evaluate VP-102 for the Treatment of Molluscum Contagiosum. J Drugs Dermatol. 2021 Jan 1;20(1):70-75. doi: 10.36849/JDD.5626.

  PMID: 33400412 DERIVED

MeSH Terms

Conditions

Molluscum Contagiosum

Interventions

VP-102

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Susan Cutler, VP, Medical Affairs
• Organization: Verrica Pharmaceuticals

scutler@verrica.com

484-773-0898

Study Officials

• Gary Goldenberg, MD

  Verrica Pharmaceuticals Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 14, 2017
• Study Start: June 8, 2017
• Primary Completion: June 25, 2018
• Study Completion: June 25, 2018
• Last Updated: August 11, 2021
• Results First Posted: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)