A Dose Range-Finding Phase 2 Trial of a Botanical Drug for the Treatment of Molluscum Contagiosum in Pediatric Subjects

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2015 by ViroXis Corporation
Sponsor:
Information provided by (Responsible Party):
ViroXis Corporation
ClinicalTrials.gov Identifier:
NCT02024581
First received: December 19, 2013
Last updated: July 16, 2015
Last verified: July 2015
  Purpose

This trial will examine the safety, tolerability and efficacy of one strength of East Indian sandalwood oil (EISO) in a cream base compared to a placebo for treatment of molluscum contagiosum in pediatric subjects. Trial participants will be asked to apply study medication twice a day for sixty (60) days. Efficacy will be evaluated by clinical staff and patients will be asked to assess tolerability as well as any improvement experienced during the trial.


Condition Intervention Phase
Molluscum Contagiosum
Drug: 10% East Indian sandalwood oil cream
Drug: Placebo Cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-center, Double-blind, Placebo-controlled, Randomized Safety and Efficacy Trial of a Botanical Drug Product, East Indian Sandalwood Oil (EISO), at One Dose Level for the Treatment of Molluscum Contagiosum in Pediatric Subjects

Further study details as provided by ViroXis Corporation:

Primary Outcome Measures:
  • Safety profile of the treatment [ Time Frame: Monitored throughout the trial (90 Days) ] [ Designated as safety issue: Yes ]
    The primary purpose of this study is to determine the safety profile of VIR003. Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug compared to placebo.


Secondary Outcome Measures:
  • Change in lesion count [ Time Frame: Measured at Day 90 ] [ Designated as safety issue: No ]
    Percent change in lesion count from Baseline to Study Day 90 in evaluable subjects

  • Improvement in GAIS score [ Time Frame: Measured at Day 90 ] [ Designated as safety issue: No ]
    Percentage of subjects who are very much improved, much improved, or improved (treatment success) at Day 90, as judged by the Global Aesthetic Improvement Scale (GAIS).

  • Complete resolution of lesions [ Time Frame: Measured at Day 90 ] [ Designated as safety issue: No ]
    1. The percentage of subjects with complete resolution of molluscum contagiosum lesion at Study Day 90 in evaluable subjects. The percentage of subjects with complete resolution of molluscum contagiosum lesion at Study Day 90 in evaluable subjects.

  • Improvement in Evaluator's Global Severity Score (EGSS) [ Time Frame: Measured at Day 90 ] [ Designated as safety issue: No ]
    Percentage of subjects with a baseline Evaluator's Global Severity Score (EGSS) of "moderate" or worse who are "clear" or "almost clear," or have at least a two-grade improvement at Day 90 as judged by the EGSS.


Estimated Enrollment: 60
Study Start Date: September 2015
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 10% East Indian sandalwood oil cream
East Indian sandalwood oil in a cream formulation administered twice a day for ninety (90) days
Drug: 10% East Indian sandalwood oil cream
A topical oil/water emulsion cream containing 10% East Indian sandalwood oil (EISO)
Other Names:
  • Albuterpenoids
  • EISO
Placebo Comparator: Placebo cream
A scented cream formulation administered twice a day for ninety (90) days
Drug: Placebo Cream
A sandalwood-scented oil/water emulsion topical cream matching the appearance of the active comparator creams

Detailed Description:

This trial will be a single-center, double-blind, randomized, placebo-controlled safety and efficacy trial to evaluate the efficacy and safety of VIR003 treatment regimen when administered to pediatric subjects with molluscum contagiosum.

Once subject eligibility is confirmed the subject will start the Treatment Period of the study. All subjects will receive active treatment or placebo with the first dose applied at the Day 0 Study Visit. Subjects will be instructed on how to apply the study medication twice a day for 90 days of treatment. Subjects will return to the clinic on Study Days, 7, 14, 30, 45, 60 and 90 for routine evaluations and then on Study Day 97 for the Final Study Visit.

Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug. In addition tolerability evaluations will be performed at each study visit.

The preliminary efficacy evaluation for the study will be the resolution of molluscum contagiosum lesions at Study Day 90 in evaluable subjects.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects will be included in the trial if they meet all of the following criteria:

  • Are between 2 and 17 years of age, inclusive, at screening.
  • Have a diagnosis of molluscum contagiosum that is treatable with a topical agent and at least five (5) lesions on the treatment area.
  • Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator will interfere with the study results or increase the risk of adverse events.
  • Are willing to refrain from using non-approved lotions, sunscreen, moisturizer, cleansers, cosmetics or creams on the affected areas during the treatment period.
  • Whose parent or guardian is able to give written informed consent and potential pediatric subjects 7 years of age or older to provide assent in a manner approved by the Institutional Review Board and comply with the requirements of the study.

Exclusion Criteria:

Subjects will be excluded from the trial if they meet any of the following criteria:

  • Are immunosuppressed.
  • Have regular physical contact with a sibling or other person with molluscum contagiosum virus (MCV), unless that person is also enrolled in the study.
  • Have used or are planning to use immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) in the previous 30 days.
  • Are undergoing treatment or have been treated in the last 30 days prior to Screening with isotretinoin or any other type of topical therapy (e.g., corticosteroids, cantharidin, podophyllin, podofilox, iodine, salicylic acid, retinoids, diclofenac, hyaluronic acid, potassium hydroxide, imiquimod).
  • Have used liquid nitrogen in the treatment area in the last 30 days prior to Screening.
  • Have undergone curettage, electrocoagulation, taping or clamping of the infected area.
  • Are taking antiviral medication including but not limited to cimetidine and cidofovir.
  • Have any active skin malignancy or infection other than molluscum contagiosum.
  • Have a molluscum contagiosum infection in an untreatable area (i.e., mucosal surfaces, anogenital, periorbital, and facial regions).
  • Have any condition that in the opinion of the investigator would confound the safety and/or efficacy assessments.
  • Have participated in any clinical trial in the previous 30 days.
  • Have a known sensitivity to any of the constituents of the test product including sensitivities to sandalwood oil, fragrances or any member of the Compositae family of vascular plants (e.g., sunflowers, daisies, dahlias, etc.).
  • Are pregnant, breastfeeding, or unwilling to practice an acceptable form of birth control during the study, if applicable.
  • Have a present condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02024581

Contacts
Contact: John C. Browning, MD FAAD FAAP (210) 829-5180 drbrowning@texasdls.com

Locations
United States, Texas
Texas Dermatology and Laser Specialists Not yet recruiting
San Antonio, Texas, United States, 78218
Contact: Valerie A. Cozad, CRC    210-829-5180 ext 308    vcozad@texasdls.com   
Sponsors and Collaborators
ViroXis Corporation
Investigators
Principal Investigator: John C. Browning, MD FAAD FAAP Texas Dermatology and Laser Specialists
  More Information

No publications provided

Responsible Party: ViroXis Corporation
ClinicalTrials.gov Identifier: NCT02024581     History of Changes
Other Study ID Numbers: VIR003-01
Study First Received: December 19, 2013
Last Updated: July 16, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by ViroXis Corporation:
pediatric
dermatology
East Indian sandalwood oil
pox virus

Additional relevant MeSH terms:
Molluscum Contagiosum
DNA Virus Infections
Poxviridae Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Virus Diseases

ClinicalTrials.gov processed this record on August 31, 2015