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OpenTrials
Completed

NCT Number: NCT00713349

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dept. of Dermatology, Wake Forrest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xenaderm Vehicle

Drug

Ointment to be applied three times a day on cryo-surgery wound for 21 days.

Other names: Subject acts as own control

Placebo Comparator

Other

Ointment to be applied three times a day on cryo-surgery wound for 21 days.

Other names: Subject acts as own control

Primary outcomes

  1. Complete Wound Closure

    Time frame: 21 Days

    Each subject acting as their own control

Sponsors and collaborators

Lead sponsor

Healthpoint

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 11, 2008
Registry last updated
Dec 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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