Study to Determine if Fibrin Affects the Ability of a Wound to Heal

An Open-label, Randomized, Evaluator-Blinded Study of the Effect of Polymerized Fibrin Applied Topically Once Per Week, on Healing of Induced Thermal Wounds, Versus Weekly Application of White Petrolatum

NCT01253135•Healthpoint

View on ClinicalTrials.gov

Summary

The objective of this study is to evaluate the potential inhibitory effects of HP802-247 Vehicle on wound closure (healing), by comparing mean days to closure of superficial (partial-thickness) thermal wounds against similar wounds treated with white petrolatum.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.

Exclusion Criteria

•Have a history of dermatomyositis, systemic sclerosis, scleroderma, Sjögren's syndrome, systemic lupus erythematosus, discoid lupus, Ehler 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.
•The Principal Investigator may declare any subject ineligible for a valid medical reason.

Locations (1)

Dept of Dermatology, University of Miami

Miami, Florida, United States

Key Dates

Start Date

January 1, 2011

Primary Completion Date

July 1, 2011

Completion Date

November 1, 2011

Last Updated

December 21, 2015

Enrollment

ACTUAL participants

Conditions

Effect of Test Articles on the Healing of a Wound Artificially Induced by Liquid Nitrogen Spray

Interventions

Fibrin

BIOLOGICAL

White Petrolatum

OTHER