Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Evaluator Blinded, Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing of Induced Thermal Wounds

Conditions
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Wounds

Intervention / Treatment
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* Drug: Xenaderm Vehicle
* Other: Placebo comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Xenaderm Vehicle | Drug: Xenaderm Vehicle<br>* Ointment to be applied three times a day on cryo-surgery wound for 21 days.<br>* Other names: Subject acts as own control;|
| Placebo Comparator: 2<br>Placebo Comparator | Other: Placebo comparator<br>* Ointment to be applied three times a day on cryo-surgery wound for 21 days.<br>* Other names: Subject acts as own control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Wound Closure | Each subject acting as their own control | 21 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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White, Petrolatum, Xenaderm, Vehicle, Partial thickness wounds, Healing, Cryo-surgery