WoundsPhase 2NCT00713349
Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing
A Phase 2 study of Wounds, run by Healthpoint at 1 site in United States.
Trial summary
The objective of the study is to compare the healing of wounds induced by cryo-injury when treated with white petrolatum versus an ointment vehicle. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wounds
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Sep 2008
- Phase
- Phase 2
- 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
- Subjects will be considered qualified for enrollment if they:
- Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks and contact information.
- Are male or female, ≥ 18 years of age, of any race.
- Are willing to attend all required study visits, and to comply with study procedures.
- Meet none of the exclusion criteria (any single exclusion criterion which is met by a potential subject will disqualify that subject from participation in this study).
Who cannot join
- Subjects will be considered NOT qualified for enrollment if they:
- Have a history of dermatomyositis, systemic sclerosis, scleroderma, Sjögren's syndrome, systemic lupus erythematosis, discoid lupus, Ehler's Danlos disease, icthyosis vulgaris, vasculitis or bleeding disorders (coagulopathies).
- Have any dermatologic disease which may be aggravated or provoked by the wounding procedure, such as Lichen Planus, Psoriasis or Vitiligo.
- Have Fitzpatrick scale skin type 6 (never sunburns, deeply pigmented).
- Are at risk of keloid or hypertrophic scar formation, based on personal history, family history, or brief skin exam (conducted at the screening visit to look for keloids or hypertrophic scars).
- Have been treated within the last three months for uncontrolled diabetes mellitus, peripheral vascular disease, vitamin C deficiency, connective tissue disorders, or any other disease process that impedes wound healing.
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- Are taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs.
- Are using topical glycolic acid products, alpha-hydroxy acid products, retinoids or chemical peel agents in the treatment areas.
- Are using systemic steroids or immunosuppressant agents, or have used these drugs within the past three months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dept. of Dermatology, Wake Forrest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized, Evaluator Blinded, Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing of Induced Thermal Wounds
The objective of the study is to compare the healing of wounds induced by cryo-injury when treated with white petrolatum versus an ointment vehicle.
- Conditions
- Wounds
- Being tested
- Xenaderm Vehicle, Placebo comparator
- Keywords
- White, Petrolatum, Xenaderm, Vehicle, Partial thickness wounds, Healing, Cryo-surgery
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenaderm VehicleDrug
Also called Subject acts as own control
Ointment to be applied three times a day on cryo-surgery wound for 21 days.
Placebo comparatorOther
Also called Subject acts as own control
Ointment to be applied three times a day on cryo-surgery wound for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Xenaderm Vehicle Receives: Drug: Xenaderm Vehicle |
| 2 | Placebo comparator | Placebo Comparator Receives: Other: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Wound Closure
Each subject acting as their own control
Measured: 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2008
- Study completionSep 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 WoundsStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert R Slade, MD, Study chair, HealthpointD. Innes Cargill, PhD, Study director, HealthpointSteven R Feldman, MD, PhD, Principal investigator, Wake Forest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713349
- Sponsor's protocol ID
- 011-101-09-004
- Status last verified
- Oct 2013
- First submitted
- 9 Jul 2008
- Last updated
- 6 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Evaluator Blinded, Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing of Induced Thermal Wounds
- ClinicalTrials.gov ID
- NCT00713349
- Acronym / sponsor ID
- 011-101-09-004
- Conditions
- Wounds
- Keywords
- White, Petrolatum, Xenaderm, Vehicle, Partial thickness wounds, Healing, Cryo-surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Jul 2008 (estimated)
- Results
- Posted 6 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to compare the healing of wounds induced by cryo-injury when treated with white petrolatum versus an ointment vehicle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Xenaderm VehicleXenaderm Vehicle |
| 2 | Placebo comparator | Other: Placebo comparatorPlacebo Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks and contact information.
- Are male or female, ≥ 18 years of age, of any race.
- Are willing to attend all required study visits, and to comply with study procedures.
- Meet none of the exclusion criteria (any single exclusion criterion which is met by a potential subject will disqualify that subject from participation in this study).
Key exclusion criteria (9 listed)
- Have a history of dermatomyositis, systemic sclerosis, scleroderma, Sjögren's syndrome, systemic lupus erythematosis, discoid lupus, Ehler's Danlos disease, icthyosis vulgaris, vasculitis or bleeding disorders (coagulopathies).
- Have any dermatologic disease which may be aggravated or provoked by the wounding procedure, such as Lichen Planus, Psoriasis or Vitiligo.
- Have Fitzpatrick scale skin type 6 (never sunburns, deeply pigmented).
- Are at risk of keloid or hypertrophic scar formation, based on personal history, family history, or brief skin exam (conducted at the screening visit to look for keloids or hypertrophic scars).
- Have been treated within the last three months for uncontrolled diabetes mellitus, peripheral vascular disease, vitamin C deficiency, connective tissue disorders, or any other disease process that impedes wound healing.
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 |
|---|---|---|
| Xenaderm VehicleAlso: Subject acts as own controlOintment to be applied three times a day on cryo-surgery wound for 21 days. | Drug | 1 |
| Placebo comparatorAlso: Subject acts as own controlOintment to be applied three times a day on cryo-surgery wound for 21 days. | Other | 2 |
Primary outcome
Complete Wound Closure
Time frame: 21 Days
Each subject acting as their own control
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2013.
- 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.
Herbert R Slade, MD study chair
Healthpoint
D. Innes Cargill, PhD study director
Healthpoint
Steven R Feldman, MD, PhD principal investigator
Wake Forest
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 of Wounds, 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 5 inclusion and 9 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 6 Dec 2013. 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?
Yes. Results are posted in the registry (first posted 6 Dec 2013). 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?
Complete Wound Closure (time frame: 21 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 6 Dec 2013.