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

• Status: Terminated
• Trial end date: 2017-09-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ViroXis Corporation

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.