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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT00713349
First received: July 9, 2008
Last updated: October 9, 2013
Last verified: October 2013

July 9, 2008
October 9, 2013
June 2008
August 2008   (final data collection date for primary outcome measure)
Complete Wound Closure [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
Each subject acting as their own control
Complete Wound Closure [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00713349 on ClinicalTrials.gov Archive Site
Not Provided
Adverse Events [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing
A Randomized, Evaluator Blinded, Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing of Induced Thermal Wounds

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Wounds
  • Drug: Xenaderm Vehicle
    Ointment to be applied three times a day on cryo-surgery wound for 21 days.
    Other Name: Subject acts as own control
  • Other: Placebo comparator
    Ointment to be applied three times a day on cryo-surgery wound for 21 days.
    Other Name: Subject acts as own control
  • 1
    Xenaderm Vehicle
    Intervention: Drug: Xenaderm Vehicle
  • Placebo Comparator: 2
    Placebo Comparator
    Intervention: Other: Placebo comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
September 2008
August 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00713349
011-101-09-004
No
Healthpoint
Healthpoint
Not Provided
Study Chair: Herbert R Slade, MD Healthpoint
Study Director: D. Innes Cargill, PhD Healthpoint
Principal Investigator: Steven R Feldman, MD, PhD Wake Forest
Healthpoint
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP