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

Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713349
• Other study ID #: 011-101-09-004
• Status: Completed
• Phase: Phase 2
• First received: July 9, 2008
• Last updated: October 9, 2013
• Start date: June 2008
• Est. completion date: September 2008

Study information

• Verified date: October 2013
• Source: Healthpoint
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Other known NCT identifiers

• NCT00693810

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wounds

Intervention

Drug:
• Xenaderm Vehicle
Ointment to be applied three times a day on cryo-surgery wound for 21 days.

Other:
• Placebo comparator
Ointment to be applied three times a day on cryo-surgery wound for 21 days.

Locations

Country	Name	City	State
United States	Dept. of Dermatology, Wake Forrest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Wound Closure	Each subject acting as their own control	21 Days	No