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.

Study Overview

• Status: Completed
• Conditions: Wounds
• Intervention / Treatment: Drug: Xenaderm Vehicle; Other: Placebo comparator

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Dept. of Dermatology, Wake Forrest School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Xenaderm Vehicle	Drug: Xenaderm Vehicle; Ointment to be applied three times a day on cryo-surgery wound for 21 days.; Other Names: 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 Names: Subject acts as own control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Wound Closure	Each subject acting as their own control	21 Days

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: July 9, 2008
• First Submitted That Met QC Criteria: July 10, 2008
• First Posted (Estimate): July 11, 2008

Study Record Updates

• Last Update Posted (Estimate): December 6, 2013
• Last Update Submitted That Met QC Criteria: October 9, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Healing; White; Petrolatum; Xenaderm; Vehicle; Partial thickness wounds; Cryo-surgery
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 011-101-09-004