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
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2010
CompletedFirst Posted
Study publicly available on registry
December 3, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
December 21, 2015
CompletedDecember 21, 2015
December 1, 2015
6 months
November 30, 2010
December 17, 2015
December 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Control
PLACEBO COMPARATORWhite Petrolatum
Test article
OTHERVehicle (fibrinogen)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Healthpointlead
Study Sites (1)
Dept of Dermatology, University of Miami
Miami, Florida, 33136, United States
Related Publications (1)
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.
PMID: 26151791DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jaime E Dickerson, PhD
- Organization
- Smith & Nephew
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2010
First Posted
December 3, 2010
Study Start
January 1, 2011
Primary Completion
July 1, 2011
Study Completion
November 1, 2011
Last Updated
December 21, 2015
Results First Posted
December 21, 2015
Record last verified: 2015-12