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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03336372
Other study ID # IIS-Picato-1386
Secondary ID
Status Withdrawn
Phase Early Phase 1
First received
Last updated
Start date December 20, 2017
Est. completion date October 16, 2018

Study information

Verified date March 2022
Source Center for Clinical Studies, Texas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 16, 2018
Est. primary completion date September 8, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Picato
Picato 0.05% or 0.015% topical gel applied nightly for 3 consecutive nights

Locations

Country Name City State
United States Center for Clinical Studies Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
Center for Clinical Studies, Texas LEO Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Treatment Satisfaction Questionnaire for Medication Scale range from "extremely satisfied" to "extremely dissatisfied". 24 weeks
Other EQ-5D-5L Index and Health Status Scale range from 0 (worst health) to 100 (best health). 24 weeks
Primary Complete clearance at Week 4 Complete clearance is defined as no clinically visible MCs in the treatment area/ 4 weeks
Secondary Partial clearance at Week 4 Partial clearance defined as at least 50% reduction in the number of clinically visible MCs in the treatment area. 4 weeks
Secondary Percentage of subjects who sustain complete clearance of MCs in the treatment area at Week 24 24 weeks
Secondary Percentage of subjects who clear MCs outside of the treatment area at Week 24 24 weeks
See also
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Completed NCT01348386 - Efficacy and Tolerance of Potassium Hydroxide (10% and 15%) in Molluscum Contagiosum Phase 2/Phase 3
Completed NCT05634460 - Comparison of 5% Potassium Hydroxide With 10% Potassium Hydroxide Solution in Treatment of Molluscum Contagiosum Phase 1
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Recruiting NCT02759900 - Using a Cold Atmospheric Plasma Device to Treat Skin Disorders N/A
Completed NCT05680181 - Study of a Cohort of Children With Molluscum Contagiosum (MC) Treated With a 5% Solution of Potassium Hydroxide (Molutrex®) Applied Locally to the Skin
Completed NCT03077750 - A Study of VBP-245 in Pediatric Patients With Molluscum Contagiosum Phase 2
Terminated NCT02024581 - A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Molluscum Contagiosum Phase 2
Completed NCT03377803 - Cantharidin Application in Molluscum Patients Phase 3