Study to Determine if Fibrin Affects the Ability of a Wound to Heal
Condition: Effect of Test Articles on the Healing of a Wound Artificially Induced by Liquid Nitrogen Spray
MeSH terms: Wounds and Injuries
Intervention: Fibrin; White Petrolatum
Intervention description: Topical application of fibrinogen spray, followed by thrombin spray; Topical application
Intervention MeSH terms: Petrolatum
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fibrin, white petrolatum, wound healing

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 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 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.