Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing
Primary Purpose
Wounds
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Xenaderm Vehicle
Placebo comparator
Sponsored by
About this trial
This is an interventional treatment trial for Wounds focused on measuring White, Petrolatum, Xenaderm, Vehicle, Partial thickness wounds, Healing, Cryo-surgery
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.
Sites / Locations
- Dept. of Dermatology, Wake Forrest School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Placebo Comparator
Arm Label
1
2
Arm Description
Xenaderm Vehicle
Placebo Comparator
Outcomes
Primary Outcome Measures
Complete Wound Closure
Each subject acting as their own control
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00713349
Brief Title
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
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Healthpoint
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
Keywords
White, Petrolatum, Xenaderm, Vehicle, Partial thickness wounds, Healing, Cryo-surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Xenaderm Vehicle
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Xenaderm Vehicle
Other Intervention Name(s)
Subject acts as own control
Intervention Description
Ointment to be applied three times a day on cryo-surgery wound for 21 days.
Intervention Type
Other
Intervention Name(s)
Placebo comparator
Other Intervention Name(s)
Subject acts as own control
Intervention Description
Ointment to be applied three times a day on cryo-surgery wound for 21 days.
Primary Outcome Measure Information:
Title
Complete Wound Closure
Description
Each subject acting as their own control
Time Frame
21 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert R Slade, MD
Organizational Affiliation
Healthpoint
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
D. Innes Cargill, PhD
Organizational Affiliation
Healthpoint
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Steven R Feldman, MD, PhD
Organizational Affiliation
Wake Forest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Dermatology, Wake Forrest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing
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