HealthyPhase 1NCT00644917

Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment

A Phase 1 study testing Xenaderm in people with Healthy, run by Healthpoint.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The product is being tested to see if exposure to light causes toxic 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?: Yes, some participants may receive a placebo
How many people: 38 participants
Where: No sites listed yet
Study dates: Feb 2008to Feb 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

Under 18 years of age

About this study

The product is being tested to see if exposure to light causes toxic reactions on the skin.

Conditions: Healthy
Being tested: Xenaderm, Placebo
Keywords: wound healing, phototoxicity, Healthy Subjects
Medical subject headings: Dermatitis, Phototoxic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

XenadermDrug
20mg under Finn chambers
PlaceboDrug
20mg under Finn chambers

Study groups in NCT00644917
Study group	Role	What they receive
A	Experimental	Drug Receives: Drug: Xenaderm
B	Placebo comparator	Placebo comparator Receives: Drug: Placebo
C	No intervention	Subjects serve as own controls.

What is being measured

The primary outcome is the main question the study is designed to answer.

Skin Reaction Score
Scores for phototoxic skin irritation were used to evaluate safety. In this study, irritation was graded using a scale that ranged from 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units.
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Feb 2008

First posted27 Mar 2008 (estimated)
Study startFeb 2008
Primary completionFeb 2008
Study completionFeb 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: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00644917
Sponsor's protocol ID: 011 101 09 001
Status last verified: Dec 2013
First submitted: 24 Mar 2008
Last updated: 13 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment
ClinicalTrials.gov ID: NCT00644917
Acronym / sponsor ID: 011 101 09 001
Conditions: Healthy
Keywords: wound healing, phototoxicity, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: HealthpointIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 27 Mar 2008 (estimated)
Results: Posted 13 Jan 2014

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 toxic reactions on the skin.

Study design

Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
A	Experimental	Drug: XenadermDrug
B	Placebo comparator	Drug: PlaceboPlacebo comparator
C	No intervention	–Subjects serve as own controls.

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)

Under 18 years of age

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
Xenaderm20mg under Finn chambers	Drug	A
Placebo20mg under Finn chambers	Drug	B

Primary outcome

Skin Reaction Score
Time frame: 48 hours
Scores for phototoxic skin irritation were used to evaluate safety. In this study, irritation was graded using a scale that ranged from 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units.

Results and safety

Results posted to the registry on 13 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Xenaderm Ointment - Subjects Acted as Own Comparator	38	36

Primary outcome: Skin Reaction Score

Time frame: 48 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Xenaderm Ointment - Irradiated n = 36	Xenaderm Vehicle - Irradiated n = 36	Control - Irradiated n = 36	Xenaderm Ointment - Non-irradiated n = 36	Xenaderm Vehicle - Non-irradiated n = 36
Day 2 at patch removal	0.4 (0.5)	0.5 (0.6)	0.1 (0.2)	0.4 (0.5)	0.5 (0.6)
Day 2 immediately post UV radiation	0.3 (0.6)	0.7 (0.9)	0.5 (0.8)	0.2 (0.5)	0.4 (0.6)
Day 3 - 24 hours post UV radiation	0.5 (1.0)	0.8 (1.1)	0.9 (1.1)	0.3 (0.6)	0.2 (0.4)
Day 4 - 48 hours post UV radiation	0.4 (0.8)	0.6 (1.0)	0.7 (1.1)	0.2 (0.5)	0.2 (0.5)

Population analysed: Intent-to-Treat (ITT)

Adverse events

Time frame: All subjects were exposed to Xenaderm Ointment and Xenaderm vehicle at Day 1. The exposures were occluded under Finn Chambers for 24 hours.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Xenaderm Ointment - Subjects Acted as Own Comparator	0 of 36 (0%)	3 of 36 (8.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
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.

Innes Cargill, PhD study director

Healthpoint, Ltd.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Xenaderm in people with Healthy, run by Healthpoint.

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 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

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 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 13 Jan 2014). 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?

Skin Reaction Score (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00644917.

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 13 Jan 2014.