- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03336372
Picato for the Treatment of Molluscum Contagiosum in Immunocompromised Patients
March 21, 2022 updated by: Center for Clinical Studies, Texas
Patients at least 18 years of age will be enrolled in the study to assess the efficacy and tolerability of Picato gel in the treatment of molluscum contagiosum.
Patients must have an immunocompromised condition due to taking immunosuppressive drugs or having an inherited disease affecting the immune system.
Study Overview
Study Type
Interventional
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Houston, Texas, United States, 77004
- Center for Clinical Studies
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or non-pregnant female at least 18 years of age.
- Subject must have an immunocompromised condition due to use of immunosuppressive therapies for cancer or autoimmune disease treatment or prevention of organ transplant rejection or due to an inherited condition that affects the immune system.
Subject has at least 10 clinically typical, visible and discrete MCs within a treatment area on either the face and/or trunk. Treatment area is defined as either:
- One contiguous treatment area of at most 100 cm2
- Two non-contiguous treatment areas totaling at most 100 cm2
- Subject must be willing to forego any other treatments of MC on the face and/or trunk, including tanning bed use and excessive sun exposure, throughout the duration of the trial.
- Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods, and to comply with all study requirements.
- Female subjects of childbearing potential must have a negative urine pregnancy test prior to trial treatment.
- Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until the last follow-up visit at Week 24.
Exclusion Criteria:
Location of the treatment area
- on the periorbital skin
- within 5 cm of an incompletely healed wound
- within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
- Previous participation in an ingenol mebutate trial.
- Treatment with ingenol mebutate gel in the treatment area within 6 months or outside of the treatment area within 30 days prior to study treatment initiation.
Receipt of the following within 90 days prior to study treatment initiation:
- interferons or interferon inducers
- any dermatologic procedures or surgeries within the treatment area
- Receipt of any topical prescription medications in the treatment area within 30 days prior to study treatment initiation.
- Lesions in the treatment area have atypical clinical appearance (e.g. giant lesions greater than 5 mm, eczematous lesions, or folliculocentric lesions).
- Active dermatologic conditions that may confound the diagnosis of MC or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, or psoriasis.
- Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a severe AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the (sub)investigator's clinical judgment.
- Known history of infection with Human Immunodeficiency Virus (HIV).
- History of melanoma.
- History of chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance as judged by the (sub)investigator.
- Known or suspected allergy or reaction to any component of the IMP formulation.
- Patients who have experienced a clinically important medical event within 90 days prior to study treatment initiation (e.g., stroke, myocardial infarction, etc).
- Pregnant, breastfeeding, or lactating women.
- Participation in any another interventional clinical trial within 30 days prior to study treatment initiation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Picato topical gel
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Picato 0.05% or 0.015% topical gel applied nightly for 3 consecutive nights
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete clearance at Week 4
Time Frame: 4 weeks
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Complete clearance is defined as no clinically visible MCs in the treatment area/
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Partial clearance at Week 4
Time Frame: 4 weeks
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Partial clearance defined as at least 50% reduction in the number of clinically visible MCs in the treatment area.
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4 weeks
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Percentage of subjects who sustain complete clearance of MCs in the treatment area at Week 24
Time Frame: 24 weeks
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24 weeks
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Percentage of subjects who clear MCs outside of the treatment area at Week 24
Time Frame: 24 weeks
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24 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Satisfaction Questionnaire for Medication
Time Frame: 24 weeks
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Scale range from "extremely satisfied" to "extremely dissatisfied".
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24 weeks
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EQ-5D-5L Index and Health Status
Time Frame: 24 weeks
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Scale range from 0 (worst health) to 100 (best health).
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24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Stephen K Tyring, MD, PhD, Center for Clinical Studies
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 20, 2017
Primary Completion (ACTUAL)
September 8, 2018
Study Completion (ACTUAL)
October 16, 2018
Study Registration Dates
First Submitted
November 6, 2017
First Submitted That Met QC Criteria
November 6, 2017
First Posted (ACTUAL)
November 8, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 1, 2022
Last Update Submitted That Met QC Criteria
March 21, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIS-Picato-1386
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Molluscum Contagiosum
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University of North Carolina, Chapel HillNational Center for Research Resources (NCRR); Doris Duke Charitable FoundationCompleted
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Medical University of South CarolinaThe Skin Center Dermatology GroupCompletedVerruca Vulgaris | Molluscum Contagiosum Skin InfectionUnited States
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Novan, Inc.Synteract, Inc.CompletedMolluscum ContagiosumUnited States
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Verrica Pharmaceuticals Inc.Paidion Research, Inc.; Instat Consulting, Inc.; Database Integrations, Inc.Completed
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Steven R CohenCompletedMolluscum ContagiosumUnited States
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Montefiore Medical CenterCompleted
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Combined Military Hospital AbbottabadCompletedComparative Efficacy of 10% Potassium Hydroxide Solution Versus Cryotherapy in Molluscum ContagiosumMolluscum ContagiosumPakistan
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Novan, Inc.Synteract, Inc.CompletedMolluscum ContagiosumUnited States
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Combined Military Hospital AbbottabadCompletedMolluscum ContagiosumPakistan
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Dalia Mahranassistant professor Ghada M. Khafagy; Dr. Marwa Diaaeldeen Abbass Hasan; Prof...UnknownMolluscum ContagiosumEgypt
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