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

Primary Purpose

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

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Fibrin

White Petrolatum

About this trial

This is an interventional treatment trial for Effect of Test Articles on the Healing of a Wound Artificially Induced by Liquid Nitrogen Spray focused on measuring Fibrin, white petrolatum, wound healing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Dept of Dermatology, University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Other

Arm Label

Control

Test article

Arm Description

White Petrolatum

Vehicle (fibrinogen)

Outcomes

Primary Outcome Measures

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).

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT01253135

First Posted

November 30, 2010

Last Updated

December 17, 2015

Sponsor

Healthpoint

1. Study Identification

Unique Protocol Identification Number

NCT01253135

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Healthpoint

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Fibrin, white petrolatum, wound healing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

White Petrolatum

Arm Title

Test article

Arm Type

Other

Arm Description

Vehicle (fibrinogen)

Intervention Type

Biological

Intervention Name(s)

Fibrin

Intervention Description

Topical application of fibrinogen spray, followed by thrombin spray

Intervention Type

Other

Intervention Name(s)

White Petrolatum

Intervention Description

Topical application

Primary Outcome Measure Information:

Title

Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements.

Description

The target wounds were evaluated wound status (open/closed).

Time Frame

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

Title

Median Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements.

Description

The target wounds were evaluated wound status (open/closed)

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Dept of Dermatology, University of Miami

City

Miami.

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26151791

Citation

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.

Results Reference

derived

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

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