Molluscum ContagiosumPhase 2NCT02024581
A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Molluscum Contagiosum
A Phase 2 study testing 10% East Indian sandalwood oil cream in people with Molluscum Contagiosum, run by ViroXis Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Molluscum Contagiosum
- What is being tested?
- 10% East Indian sandalwood oil cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 21 Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
About this study
Official title: A Multi-center, Double-blind, Placebo-controlled, Randomized Safety and Efficacy Trial of a Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) for the Treatment of Molluscum Contagiosum in Pediatric Subjects
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.
Read the 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 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.
- Conditions
- Molluscum Contagiosum
- Being tested
- 10% East Indian sandalwood oil cream, Placebo Cream
- Keywords
- pediatric, dermatology, East Indian sandalwood oil, pox virus
- Medical subject headings
- Molluscum Contagiosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% East Indian sandalwood oil creamDrug
Also called Albuterpenoids, EISO
A topical oil/water emulsion cream containing 10% East Indian sandalwood oil (EISO)
Placebo CreamDrug
A sandalwood-scented oil/water emulsion topical cream matching the appearance of the active comparator creams
| Study group | Role | What they receive |
|---|---|---|
| 10% East Indian sandalwood oil cream | Active comparator | East Indian sandalwood oil in a cream formulation administered twice a day for ninety (90) days Receives: Drug: 10% East Indian sandalwood oil cream |
| Placebo cream | Placebo comparator | A scented cream formulation administered twice a day for ninety (90) days Receives: Drug: Placebo Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Monitored throughout the trial (90 Days)
Secondary outcomes (4)
Change in lesion count
Percent change in lesion count from Baseline to Study Day 90 in evaluable subjects
Measured: Measured at Day 90
Improvement in GAIS score
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).
Measured: Measured at Day 90
Complete resolution of lesions
- 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.
Measured: Measured at Day 90
Improvement in Evaluator's Global Severity Score (EGSS)
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.
Measured: Measured at Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startFeb 2016
- Primary completionSep 2017
- Study completion21 Sep 2017
Why it stopped: Sponsor chose to close
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molluscum ContagiosumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViroXis Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John C. Browning, MD FAAD FAAP, Principal investigator, Texas Dermatology and Laser Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024581
- Sponsor's protocol ID
- VIR003-01
- Status last verified
- Apr 2019
- First submitted
- 19 Dec 2013
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Placebo-controlled, Randomized Safety and Efficacy Trial of a Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) for the Treatment of Molluscum Contagiosum in Pediatric Subjects
- ClinicalTrials.gov ID
- NCT02024581
- Acronym / sponsor ID
- VIR003-01
- Conditions
- Molluscum Contagiosum
- Keywords
- pediatric, dermatology, East Indian sandalwood oil, pox virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor chose to close
- Enrolment
- 27 participants (actual)
- Lead sponsor
- ViroXis CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- 21 Sep 2017 (actual)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10% East Indian sandalwood oil cream | Active comparator | Drug: 10% East Indian sandalwood oil creamEast Indian sandalwood oil in a cream formulation administered twice a day for ninety (90) days |
| Placebo cream | Placebo comparator | Drug: Placebo CreamA scented cream formulation administered twice a day for ninety (90) days |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% East Indian sandalwood oil creamAlso: Albuterpenoids, EISOA topical oil/water emulsion cream containing 10% East Indian sandalwood oil (EISO) | Drug | 10% East Indian sandalwood oil cream |
| Placebo CreamA sandalwood-scented oil/water emulsion topical cream matching the appearance of the active comparator creams | Drug | Placebo cream |
Primary outcome
Safety profile of the treatment
Time frame: Monitored throughout the trial (90 Days)
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.
4 secondary outcomes
Change in lesion count
Time frame: Measured at Day 90
Improvement in GAIS score
Time frame: Measured at Day 90
Complete resolution of lesions
Time frame: Measured at Day 90
Improvement in Evaluator's Global Severity Score (EGSS)
Time frame: Measured at Day 90
Results and safety
The study was stopped early (reason given: Sponsor chose to close). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John C. Browning, MD FAAD FAAP principal investigator
Texas Dermatology and Laser Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10% East Indian sandalwood oil cream in people with Molluscum Contagiosum, run by ViroXis Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor chose to close). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety profile of the treatment (time frame: Monitored throughout the trial (90 Days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.