HealthyPhase 1NCT00645164
Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment
A Phase 1 study testing Xenaderm in people with Healthy, run by Healthpoint at 1 site in United States.
Trial summary
The product is being tested to see if exposure to light causes photoallergic reactions on the skin. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Xenaderm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jun 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
Who cannot join
- Less than 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Suncare Research Laboratories
Winston-Salem, North Carolina
About this study
The product is being tested to see if exposure to light causes photoallergic reactions on the skin.
- Conditions
- Healthy
- Being tested
- Ointment Vehicle, Xenaderm
- Keywords
- wound healing, photoallergenicity, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ointment VehicleOther
Subject acts as own control. 20 mg under Finn chambers
XenadermDrug
20 mg under Finn chambers
| Study group | Role | What they receive |
|---|---|---|
| Xenaderm | Experimental | Subject serves as own control Receives: Other: Ointment Vehicle; Drug: Xenaderm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency Distribution of Skin Irritation Scores
Scores based on skin irritation scale of 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. Photoallergic reactions were characterized by irritation scores of 3 or higher.
Measured: 48-hours post irradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joe Stanfield, PhD, Principal investigator, Suncare Research Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645164
- Sponsor's protocol ID
- 011 101 09 002
- Status last verified
- Jun 2010
- First submitted
- 24 Mar 2008
- Last updated
- 8 Jun 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment
- ClinicalTrials.gov ID
- NCT00645164
- Acronym / sponsor ID
- 011 101 09 002
- Conditions
- Healthy
- Keywords
- wound healing, photoallergenicity, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 27 Mar 2008 (estimated)
- Results
- Posted 6 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The product is being tested to see if exposure to light causes photoallergic reactions on the skin.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xenaderm | Experimental | Other: Ointment Vehicle, Drug: XenadermSubject serves as own control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects
Key exclusion criteria (1 listed)
- Less than 18 years
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 |
|---|---|---|
| Ointment VehicleSubject acts as own control. 20 mg under Finn chambers | Other | Xenaderm |
| Xenaderm20 mg under Finn chambers | Drug | Xenaderm |
Primary outcome
Frequency Distribution of Skin Irritation Scores
Time frame: 48-hours post irradiation
Scores based on skin irritation scale of 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. Photoallergic reactions were characterized by irritation scores of 3 or higher.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joe Stanfield, PhD principal investigator
Suncare Research Laboratories
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Xenaderm in people with Healthy, run by Healthpoint 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 1 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 8 Jun 2010. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Frequency Distribution of Skin Irritation Scores (time frame: 48-hours post irradiation). 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 8 Jun 2010.