Picato for the Treatment of Molluscum Contagiosum in Immunocompromised Patients

NCT03336372 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: IIS-Picato-1386
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Molluscum Contagiosum

Outcome Measures

Primary Outcomes (1)

• Complete clearance at Week 4

  Complete clearance is defined as no clinically visible MCs in the treatment area/

  4 weeks

Secondary Outcomes (3)

• Partial clearance at Week 4

  4 weeks

• Percentage of subjects who sustain complete clearance of MCs in the treatment area at Week 24

  24 weeks

• Percentage of subjects who clear MCs outside of the treatment area at Week 24

  24 weeks

Other Outcomes (2)

• Treatment Satisfaction Questionnaire for Medication

  24 weeks

• EQ-5D-5L Index and Health Status

  24 weeks

Study Arms (1)

Picato topical gel

EXPERIMENTAL

Drug: Picato

Interventions

Picato DRUG

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

Picato topical gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center for Clinical Studies, Texas: lead
• LEO Pharma: collaborator

Study Sites (1)

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

MeSH Terms

Conditions

Molluscum Contagiosum

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

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

Study Officials

• Stephen K Tyring, MD, PhD

  Center for Clinical Studies

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 8, 2017
• Study Start: December 20, 2017
• Primary Completion: September 8, 2018
• Study Completion: October 16, 2018
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

US (1)