Expired Study
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Winston Salem, North Carolina 27157


Purpose:

The purpose of this research study is to evaluate the effects of the non-medicated part of Xenaderm® Ointment on the rate of healing when people use it to treat superficial (skin-deep) wounds.


Criteria:

Inclusion Criteria: - 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: - 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 is Available At:


Original ID:

00004928


NCT ID:

NCT00693810


Secondary ID:

33003


Study Acronym:


Brief Title:

Study of Xenaderm Ointment Vehicle on Healing of Induced Thermal Wounds


Official Title:

A Randomized, Evaluator Blinded, Controlled Study of the Effect of Xenaderm Ointment Vehicle on Healing of Induced Thermal Wounds, Versus White Petrolatum


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Wake Forest University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Interven


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Steve Feldman, MD, PhD
Principal Investigator
Wake Forest University

Study Dates

Start Date:June 2008
Completion Date:November 2008
Completion Type:Actual
Primary Completion Date:November 2008
Primary Completion Type:Actual
Verification Date:November 2008
Last Changed Date:November 18, 2008
First Received Date:June 5, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Difference in days to complete wound closure between the two test articles. Because each subject is exposed to both test articles, the data are paired
Time Frame:3 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Xenaderm
Description:applied three times a daily to affected areas active ingredients: Balsam Peru Oil, Castor Oil USP/NF, and Trypsin USP

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Wake Forest University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Healthpoint

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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