IntertrigoEarly Phase 1NCT01118910
Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo
A Early Phase 1 study testing Vusion in people with Intertrigo, run by Image Dermatology P.C. at 1 site in United States.
Trial summary
The purpose of this study is to determine if people with moist, red, patches on their skin in body folds would benefit treatment of those areas with an FDA-approved drug called Vusion. Read more about this study
- Who is it for?
- Ages 12 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Intertrigo
- What is being tested?
- Vusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to May 2011
- Phase
- Early Phase 1
- 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 12 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Evidence of intertrigo
Who cannot join
- Pregnancy
- Use of systemic or topical antifungal or corticosteroid treatment in the previous 14 days or during the 3-month treatment period
- allergy of sensitivity to Vusion
- undergoing warfarin anticoagulation
- alcohol or drug abuse
- Investigator determines they cannot particpate
- history of non-compliance or poor cooperation
- participation in an investigaitonal drug study within 30 days of Baseline Visit
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if people with moist, red, patches on their skin in body folds would benefit treatment of those areas with an FDA-approved drug called Vusion.
Read the detailed description
Intertrigo is an inflammatory condition of skin folds, induced or aggravated by heat, moisture, maceration, friction, or lack of air circulation. It is typically chronic with insidious onset of itching, burning, and stinging within the affected skin folds. Intertrigo frequently worsened or colonized by infection, which most commonly is candidal but also may be bacterial, fungal, or viral. The etiology of diaper dermatitis shows significant overlap with that of intertrigo. Vusion ointment, a highly effective treatment for diaper dermatitis, has been used by physicians for the treatment of intertrigo; however, there is a paucity of data in the literature regarding the use of Vusion ointment in this indication.
This study is the first to formally investigate the efficacy and safety of Vusion ointment for the treatment of intertrigo.
- Conditions
- Intertrigo
- Being tested
- Vusion
- Keywords
- Intertrigo, Vusion
- Medical subject headings
- Intertrigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VusionDrug
Vusion will be applied to areas of intertrigo
| Study group | Role | What they receive |
|---|---|---|
| Vusion ointment | Experimental | Not described Receives: Drug: Vusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients for whom Vusion effectively treated intertrigo
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntertrigoStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Image Dermatology P.C.
- Sponsor type
- University, hospital or other
- Investigators
- Jeanine B. Downie, M.D., Principal investigator, Image Dermatology P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118910
- Sponsor's protocol ID
- W0319-501
- Status last verified
- Aug 2011
- First submitted
- 6 May 2010
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo
- ClinicalTrials.gov ID
- NCT01118910
- Acronym / sponsor ID
- W0319-501
- Conditions
- Intertrigo
- Keywords
- Intertrigo, Vusion
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Image Dermatology P.C.University, hospital or other
- Study start
- Apr 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 May 2010 (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.
The purpose of this study is to determine if people with moist, red, patches on their skin in body folds would benefit treatment of those areas with an FDA-approved drug called Vusion.
Detailed description
Intertrigo is an inflammatory condition of skin folds, induced or aggravated by heat, moisture, maceration, friction, or lack of air circulation. It is typically chronic with insidious onset of itching, burning, and stinging within the affected skin folds. Intertrigo frequently worsened or colonized by infection, which most commonly is candidal but also may be bacterial, fungal, or viral. The etiology of diaper dermatitis shows significant overlap with that of intertrigo. Vusion ointment, a highly effective treatment for diaper dermatitis, has been used by physicians for the treatment of intertrigo; however, there is a paucity of data in the literature regarding the use of Vusion ointment in this indication.
This study is the first to formally investigate the efficacy and safety of Vusion ointment for the treatment of intertrigo.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vusion ointment | Experimental | Drug: Vusion |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Evidence of intertrigo
Key exclusion criteria (8 listed)
- Pregnancy
- Use of systemic or topical antifungal or corticosteroid treatment in the previous 14 days or during the 3-month treatment period
- allergy of sensitivity to Vusion
- undergoing warfarin anticoagulation
- alcohol or drug abuse
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 |
|---|---|---|
| VusionVusion will be applied to areas of intertrigo | Drug | Vusion ointment |
Primary outcome
The number of patients for whom Vusion effectively treated intertrigo
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
Related trials for Intertrigo
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Recruiting
A Pilot Study to Evaluate the Therapeutic Efficacy of Intra-Lesional Immunotherapy in Patients Aged 10-60 Years With Recalcitrant Tinea Cruris and Corporis
Tinea Corporis, Tinea Cruris
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.
Jeanine B. Downie, M.D. principal investigator
Image Dermatology P.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vusion in people with Intertrigo, run by Image Dermatology P.C. 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 4 Aug 2011. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of patients for whom Vusion effectively treated intertrigo (time frame: 3 months). 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 4 Aug 2011.