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Sponsored by: |
Healthpoint |
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Information provided by: | Healthpoint |
ClinicalTrials.gov Identifier: | NCT00713349 |
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 |
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Wounds |
Drug: Xenaderm Vehicle Other: Placebo comparator |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Single Group Assignment |
Official Title: | A Randomized, Evaluator Blinded, Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing of Induced Thermal Wounds |
Estimated Enrollment: | 20 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Xenaderm Vehicle
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Drug: Xenaderm Vehicle
Ointment to be applied three times a day on cryo-surgery wound for 21 days.
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2: Placebo Comparator
Placebo Comparator
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Other: Placebo comparator
Ointment to be applied three times a day on cryo-surgery wound for 21 days.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects will be considered qualified for enrollment if they:
Exclusion Criteria:
Subjects will be considered NOT qualified for enrollment if they:
United States, North Carolina | |
Dept. of Dermatology, Wake Forrest School of Medicine | |
Winston-Salem, North Carolina, United States, 27157 |
Study Chair: | Herbert R Slade, MD | Healthpoint |
Study Director: | D. Innes Cargill, PhD | Healthpoint |
Principal Investigator: | Steven R Feldman, MD, PhD | Wake Forest |
Responsible Party: | Healthpoint ( D. Innes Cargill, PhD - Director of Clinical Affairs ) |
Study ID Numbers: | 011-101-09-004 |
Study First Received: | July 9, 2008 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00713349 |
Health Authority: | United States: Food and Drug Administration |
White Petrolatum Xenaderm Vehicle |
Partial thickness wounds Healing Cryo-surgery |
Petrolatum |
Therapeutic Uses Dermatologic Agents Pharmacologic Actions Emollients |