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FS2 Safety and Tolerability Study in Healthy Volunteers

Primary Purpose

Cicatrix, Cicatrix, Hypertrophic, Keloid

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Acute Application of kynurenic acid cream
Chronic application of kynurenic acid cream
Sponsored by
British Columbia Professional Firefighters' Burn and Wound Healing Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cicatrix

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy males or females between the ages of 18 and 65
  • English as a primary language, or English as a second language (ESL) but completely fluent and do not require a translator

Exclusion Criteria:

  • Pregnant, or attempting to become pregnant (NB: Pregnancy tests will be administered at the screening and baseline visit.)
  • History of chronic skin conditions (e.g: eczema, psoriasis, etc.)
  • Use of oral anti-histamines in the past month
  • Use of systemic steroids in the past month
  • Chronic use of NSAIDs or other anti-inflammatory medications
  • Known immunosuppression or immunosuppressive illness
  • Known sensitivity to parabens
  • Known allergy to the the bandage adhesive
  • English as a second language (ESL) and require a translator.

Sites / Locations

  • BCPFF Burn & Wound Healing Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Acute Sensitivity Test to FS2 cream

Chronic Sensitivity Test to FS2 cream

Arm Description

Twenty (20) healthy volunteers will be assigned volunteer numbers and will have a testing areas identified by permanent marker on their backs. Pouches containing 0.00% (placebo), 0.15%, 0.25%, 0.4% and 0.5% of FS2 will be randomly applied to an occlusive, transparent dressing (Tegaderm) and applied to each test area once for 24 hours. The pouch order will be random, generated by the www.random.org list generator each application. Patients will be evaluated at 24 hours post application for skin reactions and adverse reactions by a blinded observer recorded. Before and after photographs will be taken.

Twenty (20) randomized healthy volunteers will be assigned numbers and will have a single testing area identified by permanent marker on either shoulder or upper back. Volunteers will be educated how to apply a pouch of cream to an occlusive, transparent dressing (Tegaderm) and place it on the test site every 24 hours for 30 days. The date and time of first application will be recorded. Baseline urine and serum measurements of drug concentration (presumed absent), as well as complete blood count, liver enzymes, blood urea nitrogen, and creatinine will be taken on Day 0 (the initial enrollment of each part). The volunteers will be seen in follow-up at day 1, day 5, day 15, and day 30.

Outcomes

Primary Outcome Measures

Acute skin irritation or local reaction
After application of various concentrations of the active substance, patients will be evaluated at 24 hours post application for skin reactions and adverse reactions by a blinded observer

Secondary Outcome Measures

Chronic skin irritation or local reaction
After application of various concentrations of the active substance, patients will be evaluated post application for skin reactions and adverse reactions by a blinded observer. The volunteers will be seen in follow-up at day 1, day 5, day 15, and day 30
Chronic exposure serum drug levels
After application of various concentrations of the active substance, patients will have blood taken and analyzed using high performance liquid chromatography. The volunteers will be seen in follow-up at day 1, day 5, day 15, and day 30

Full Information

First Posted
December 1, 2014
Last Updated
February 1, 2016
Sponsor
British Columbia Professional Firefighters' Burn and Wound Healing Laboratory
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1. Study Identification

Unique Protocol Identification Number
NCT02340325
Brief Title
FS2 Safety and Tolerability Study in Healthy Volunteers
Official Title
The Safety of Topically Delivered FS2 in Humans. Phase 1 Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
British Columbia Professional Firefighters' Burn and Wound Healing Laboratory

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background Scarring typically occurs after trauma, burn injury or surgery. Hypertrophic scarring presents as raised, red and itchy lesions which variably respond to various treatment modalities, such as corticosteroids, pressure garments, laser therapy, the use of silicone sheets and radiotherapy. Kynurenine, or "Fibrostop 1" (FS1), and its further breakdown products, such as kynurenic acid, or "Fibrostop 2" (FS2), are endogenous products found in many systems and have shown potential in reducing scar formation in animal studies. The aim of study is to evaluate the safety and tolerability of FS2 cream applied to the skin of healthy human subjects.
Detailed Description
Scarring typically occurs after trauma, burn injury or surgery. Hypertrophic scars (scars with excessive amounts of a protein called collagen) and keloids (hypertrophic scars that grow beyond the boundaries of the original wound) are types of abnormal scarring that are termed "dermal fibroproliferative disorders" - disorders of abnormal growth of fibrous tissue in the dermis, a layer in normal skin. These disorders present as raised, red and itchy lesions which variably respond to various treatment modalities, such as corticosteroids, pressure garments, laser therapy, the use of silicone sheets and radiotherapy. Surgical excision of hypertrophic scars or keloids often leads to recurrence resulting in cosmetic deformities and contractures. In a previous study involving a hypertrophic scar rabbit model, it was found that collagen deposition could be reduced by increasing the activity of a molecule called MMP-1 (matrix metalloproteinase 1), an enzyme inside body cells. The investigators also know from the investigators previous work that a molecule called kynurenine, a breakdown product of amino-acids, can reduce collagen deposition and possibly stimulate MMP production. Kynurenine is a breakdown product (catabolite) of the essential amino acid tryptophan used in the production of niacin - an organic compound and essential human nutrient found in food. Kynurenine is made by the enzyme indoleamine 2,3-dioxygenase (IDO) which is found in many tissues in response to activation of the immune systen, and also by the enzyme tryptophan dioxygenase, which is found in the liver. Kynurenine is further converted to kynurenic acid, or "Fibrostop 2" (FS2), carry out many functions in the body, including dilating blood vessels during inflammation and regulating the immune response. The investigators have hypothesized that improved healing outcomes in the investigators rabbit model were due to kynurenine and by-products stimulating MMP, which in turn acted on cells (fibroblasts) to reduce collagen production. This hypothesis lead to a study investigating the effects of topical 0.5% kynurenine cream treatment on MMP-1 and MMP-3 expression in fibrotic rabbit ear wound model. The results showed marked improvement in scar formation suggesting the possible use of kynurenine as an anti-fibrogenic treatment against scarring. Toxicity, pharmacodynamic, and pharmacokinetic data has been completed, and the investigators institution is now preparing to conduct its first Phase I clinical trial. The investigators objective is to evaluate the safety and tolerability of topically applied FS2 in healthy human subjects by conducting a double-blinded acute and chronic sensitivity study involving patch testing.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute Sensitivity Test to FS2 cream
Arm Type
Other
Arm Description
Twenty (20) healthy volunteers will be assigned volunteer numbers and will have a testing areas identified by permanent marker on their backs. Pouches containing 0.00% (placebo), 0.15%, 0.25%, 0.4% and 0.5% of FS2 will be randomly applied to an occlusive, transparent dressing (Tegaderm) and applied to each test area once for 24 hours. The pouch order will be random, generated by the www.random.org list generator each application. Patients will be evaluated at 24 hours post application for skin reactions and adverse reactions by a blinded observer recorded. Before and after photographs will be taken.
Arm Title
Chronic Sensitivity Test to FS2 cream
Arm Type
Other
Arm Description
Twenty (20) randomized healthy volunteers will be assigned numbers and will have a single testing area identified by permanent marker on either shoulder or upper back. Volunteers will be educated how to apply a pouch of cream to an occlusive, transparent dressing (Tegaderm) and place it on the test site every 24 hours for 30 days. The date and time of first application will be recorded. Baseline urine and serum measurements of drug concentration (presumed absent), as well as complete blood count, liver enzymes, blood urea nitrogen, and creatinine will be taken on Day 0 (the initial enrollment of each part). The volunteers will be seen in follow-up at day 1, day 5, day 15, and day 30.
Intervention Type
Drug
Intervention Name(s)
Acute Application of kynurenic acid cream
Other Intervention Name(s)
Fibrostop 2 (FS2)
Intervention Description
Pouches containing 0.00% (placebo), 0.15%, 0.25%, 0.4% and 0.5% of FS2 will be randomly applied to an occlusive, transparent dressing (Tegaderm) and applied to each test area. The pouch order will be random, generated by the www.random.org list generator each application. The study team member applying the cream will randomly choose the application sites of different concentrations of the FS2 creams and mark the corresponding cream code name on a separate sheet. This study member will not be evaluating the results and the evaluating study member will be blinded to the randomization. Patients will be evaluated at 24 hours post application for skin reactions and adverse reactions by a blinded observer recorded. Before and after photographs will be taken.
Intervention Type
Drug
Intervention Name(s)
Chronic application of kynurenic acid cream
Other Intervention Name(s)
Fibrostop 2 (FS2)
Intervention Description
Volunteers will be educated how to apply a pouch of cream to an occlusive, transparent dressing (Tegaderm) and place it on the test site every 24 hours for 30 days. The date and time of first application will be recorded. Baseline urine and serum measurements of drug concentration (presumed absent), as well as complete blood count, liver enzymes, blood urea nitrogen, and creatinine will be taken on Day 0 (the initial enrollment of each part). The volunteers will be seen in follow-up at day 1, day 5, day 15, and day 30
Primary Outcome Measure Information:
Title
Acute skin irritation or local reaction
Description
After application of various concentrations of the active substance, patients will be evaluated at 24 hours post application for skin reactions and adverse reactions by a blinded observer
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Chronic skin irritation or local reaction
Description
After application of various concentrations of the active substance, patients will be evaluated post application for skin reactions and adverse reactions by a blinded observer. The volunteers will be seen in follow-up at day 1, day 5, day 15, and day 30
Time Frame
1 month
Title
Chronic exposure serum drug levels
Description
After application of various concentrations of the active substance, patients will have blood taken and analyzed using high performance liquid chromatography. The volunteers will be seen in follow-up at day 1, day 5, day 15, and day 30
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy males or females between the ages of 18 and 65 English as a primary language, or English as a second language (ESL) but completely fluent and do not require a translator Exclusion Criteria: Pregnant, or attempting to become pregnant (NB: Pregnancy tests will be administered at the screening and baseline visit.) History of chronic skin conditions (e.g: eczema, psoriasis, etc.) Use of oral anti-histamines in the past month Use of systemic steroids in the past month Chronic use of NSAIDs or other anti-inflammatory medications Known immunosuppression or immunosuppressive illness Known sensitivity to parabens Known allergy to the the bandage adhesive English as a second language (ESL) and require a translator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Papp, MD
Organizational Affiliation
BC Professional Fire Fighters' Burn and Wound Healing Laboratory
Official's Role
Principal Investigator
Facility Information:
Facility Name
BCPFF Burn & Wound Healing Lab
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada

12. IPD Sharing Statement

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FS2 Safety and Tolerability Study in Healthy Volunteers

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