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

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.

Study Overview

• Status: Completed
• Conditions: Effect of Test Articles on the Healing of a Wound Artificially Induced by Liquid Nitrogen Spray
• Intervention / Treatment: Other: White Petrolatum; Biological: Fibrin

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami., Florida, United States, 33136
      • Dept of Dermatology, University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control; White Petrolatum	Other: White Petrolatum; Topical application
OTHER: Test article; Vehicle (fibrinogen)	Biological: Fibrin; Topical application of fibrinogen spray, followed by thrombin spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements.	The target wounds were evaluated wound status (open/closed).	All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22
Median Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements.	The target wounds were evaluated wound status (open/closed)	All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22

Collaborators and Investigators

• Sponsor: Healthpoint

Publications and helpful links

General Publications

• Vivas A, Fox JD, Baquerizo Nole KL, Maderal AD, Badiavas E, Cargill DI, Slade HB, Feldman SR, Kirsner RS. Cryo-Induced Thermal Wounds: A Human Acute Wound Model. J Drugs Dermatol. 2015 Jul;14(7):734-8.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: November 30, 2010
• First Submitted That Met QC Criteria: December 1, 2010
• First Posted (ESTIMATE): December 3, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 21, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Fibrin, white petrolatum, wound healing
• Additional Relevant MeSH Terms: Wounds and Injuries; Dermatologic Agents; Emollients; Petrolatum
• Other Study ID Numbers: 802-247-09-017