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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01253135
First received: November 30, 2010
Last updated: December 1, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Effect of Test Articles on the Healing of a Wound Artificially Induced by Liquid Nitrogen Spray
 Other: Fibrin
Other: White Petrolatum
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Petrolatum
U.S. FDA Resources

Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • Complete wound closure [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
White Petrolatum
 Other: White Petrolatum
Topical application
Test article
Vehicle (fibrinogen)
 Other: Fibrin
Topical application of fibrinogen spray, followed by thrombin spray

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253135

Locations
United States, Florida
Dept of Dermatology, University of Miami
Miami., Florida, United States, 33136
Sponsors and Collaborators
Healthpoint
  More Information

No publications provided

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01253135     History of Changes
Other Study ID Numbers: 802-247-09-017
Study First Received: November 30, 2010
Last Updated: December 1, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Healthpoint:
Fibrin, white petrolatum, wound healing

Additional relevant MeSH terms:
Petrolatum
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013