Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing
Condition: Wounds
MeSH terms: Wounds and Injuries
Intervention: Xenaderm Vehicle; Placebo comparator
Intervention description: Ointment to be applied three times a day on cryo-surgery wound for 21 days.; Ointment to be applied three times a day on cryo-surgery wound for 21 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: White; Petrolatum; Xenaderm; Vehicle; Partial thickness wounds; Healing; Cryo-surgery

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.
    

Eligibility criteria:

        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.