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

This study has been completed.
Sponsor:
Information provided by:
Healthpoint
ClinicalTrials.gov Identifier:
NCT00713349
First received: July 9, 2008
Last updated: May 17, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Wounds
 Drug: Xenaderm Vehicle
Other: Placebo comparator
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Evaluator Blinded, Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing of Induced Thermal Wounds

Resource links provided by NLM:

Drug Information available for: Petrolatum
U.S. FDA Resources

Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • Complete Wound Closure [ Time Frame: 21 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: June 2008
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Xenaderm Vehicle
 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
Placebo Comparator: 2
Placebo Comparator
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713349

Locations
United States, North Carolina
Dept. of Dermatology, Wake Forrest School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Healthpoint
Investigators
Study Chair: Herbert R Slade, MD Healthpoint
Study Director: D. Innes Cargill, PhD Healthpoint
Principal Investigator: Steven R Feldman, MD, PhD Wake Forest
  More Information

No publications provided

Responsible Party: D. Innes Cargill, PhD - Director of Clinical Affairs, Healthpoint
ClinicalTrials.gov Identifier: NCT00713349     History of Changes
Obsolete Identifiers: NCT00693810
Other Study ID Numbers: 011-101-09-004
Study First Received: July 9, 2008
Last Updated: May 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Healthpoint:
White
Petrolatum
Xenaderm
Vehicle
 Partial thickness wounds
Healing
Cryo-surgery

Additional relevant MeSH terms:
Petrolatum
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013