A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Molluscum Contagiosum

NCT02024581 | Terminated Phase 2

• 1 other identifier: VIR003-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Molluscum Contagiosum

Keywords

pediatric; dermatology; East Indian sandalwood oil; pox virus

Outcome Measures

Primary Outcomes (1)

• Safety profile of the treatment

  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.

  Monitored throughout the trial (90 Days)

Secondary Outcomes (4)

• Change in lesion count

  Measured at Day 90

• Improvement in GAIS score

  Measured at Day 90

• Complete resolution of lesions

  Measured at Day 90

• Improvement in Evaluator's Global Severity Score (EGSS)

  Measured at Day 90

Study Arms (2)

10% East Indian sandalwood oil cream

ACTIVE COMPARATOR

East Indian sandalwood oil in a cream formulation administered twice a day for ninety (90) days

Drug: 10% East Indian sandalwood oil cream

Placebo cream

PLACEBO COMPARATOR

A scented cream formulation administered twice a day for ninety (90) days

Drug: Placebo Cream

Interventions

10% East Indian sandalwood oil cream DRUG

A topical oil/water emulsion cream containing 10% East Indian sandalwood oil (EISO)

Also known as: Albuterpenoids, EISO

10% East Indian sandalwood oil cream

Placebo Cream DRUG

A sandalwood-scented oil/water emulsion topical cream matching the appearance of the active comparator creams

Placebo cream

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ViroXis Corporation: lead

Study Sites (1)

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

MeSH Terms

Conditions

Molluscum Contagiosum

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

• John C. Browning, MD FAAD FAAP

  Texas Dermatology and Laser Specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 31, 2013
• Study Start: February 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 21, 2017
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

US (1)