Clinical trial NCT00713349: Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing
Official title: A Randomized, Evaluator Blinded, Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing of Induced Thermal Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Wounds
Keywords: White
Petrolatum
Xenaderm
Vehicle
Partial thickness wounds
Healing
Cryo-surgery
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2008-07-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Complete Wound Closure
timeFrame: 21 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Dept. of Dermatology, Wake Forrest School of Medicine
state: North Carolina
Study officials:
affiliation: Healthpoint
name: Herbert R Slade, MD
role: STUDY_CHAIR
affiliation: Healthpoint
name: D. Innes Cargill, PhD
role: STUDY_DIRECTOR
affiliation: Wake Forest
name: Steven R Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: