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 December 2013 by ViroXis Corporation
Sponsor:
Information provided by (Responsible Party):
ViroXis Corporation
ClinicalTrials.gov Identifier:
NCT02024581
First received: December 19, 2013
Last updated: December 26, 2013
Last verified: December 2013
  Purpose

This trial will examine the safety, tolerability and efficacy of three strengths 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: 2.5% East Indian sandalwood oil cream
Drug: 5% East Indian sandalwood oil cream
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 Multi-Center, Double-Blind, Randomized, Placebo-Controlled Safety and Efficacy Trial of VIR003 at Three Dose Levels for the Treatment of Molluscum Contagiosum in Pediatric Subjects

Further study details as provided by ViroXis Corporation:

Primary Outcome Measures:
  • Complete resolution of lesions [ Time Frame: Outcome measured after 60 days of treatment ] [ Designated as safety issue: No ]
    The preliminary efficacy evaluation for the study will be the complete resolution of lesion following 60 days of treatment and assessed at Study Day 60.


Secondary Outcome Measures:
  • Change in lesion count [ Time Frame: Measured following 60 days of treatment ] [ Designated as safety issue: No ]
    Percent change in lesion count from Baseline to Study Day 60 in evaluable subjects

  • Improvement in GAIS score [ Time Frame: Measured following 60 days of treatment ] [ Designated as safety issue: No ]
    Percentage of subjects who are very much improved, much improved, or improved (treatment success) at Day 60, as judged by the Global Aesthetic Improvement Scale (GAIS).

  • Safety profile of the treatment [ Time Frame: Subjects will be queried for adverse events at each visit during the treatment period (Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 30), Visit 5 (Day 45) and Visit 6 (Day 60)) ] [ Designated as safety issue: Yes ]

    The primary purpose of this study is to determine the safety profile of VIR003 at 3 dose concentration.

    Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug compared to placebo.

    In addition the following cutaneous safety evaluations will be performed at each study visit.

    • Scaling on a scale of 0 to 3.
    • Erythema on a scale of 0 to 3


Other Outcome Measures:
  • Tolerability of treatment [ Time Frame: Subjects will answer treatment tolerability questions at each visit during the treatment period (Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 30), Visit 5 (Day 45) and Visit 6 (Day 60)) ] [ Designated as safety issue: No ]
    Tolerability will be assessed on a scale of 0 to 3 for itching, scaling, burning dryness and stinging. The number and percentage of subjects reporting burning, itching, scaling, erythema, dryness or stinging (Grade 1 or higher) will be tabulated by severity.


Estimated Enrollment: 200
Study Start Date: July 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2.5% East Indian sandalwood oil cream
East Indian sandalwood oil in a cream formulation administered twice a day for sixty (60) days
Drug: 2.5% East Indian sandalwood oil cream
Other Names:
  • Albuterpenoids
  • EISO
Active Comparator: 5% East Indian sandalwood oil cream
East Indian sandalwood oil in a cream formulation administered twice a day for sixty (60) days
Drug: 5% East Indian sandalwood oil cream
Other Names:
  • Albuterpenoids
  • EISO
Active Comparator: 10% East Indian sandalwood oil cream
East Indian sandalwood oil in a cream formulation administered twice a day for sixty (60) days
Drug: 10% East Indian sandalwood oil cream
Other Names:
  • Albuterpenoids
  • EISO
Placebo Comparator: Placebo cream
A scented cream formulation administered twice a day for sixty (60) days
Drug: Placebo Cream
A scented cream matching the appearance of the active comparator creams

Detailed Description:

This trial will be a multi-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 one of three active treatments 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 60 days of treatment. Subjects will return to the clinic on Study Days, 7, 14, 30, 45, and 60 for routine evaluations and then on Study Day 90 for the Final Study Visit.

The study will be monitored by a data safety monitoring board (DSMB) comprised of a medical monitor, dermatologist and statistician. The purpose of the DSMB will be to monitor the emergence of adverse events (AEs) and serious adverse events (SAEs) at periodic intervals throughout the enrollment and treatment phases of the study

  Eligibility

Ages Eligible for Study:   2 Years to 18 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 18 years of age, at Screening.
  • Have a diagnosis of molluscum contagiosum that is treatable with a topical agent.
  • 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 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 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.
  • Have a molluscum contagiosum infection in an untreatable area (i.e., periorbital, urogenital, etc.).
  • 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: December 26, 2013
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
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014