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Trial record 20 of 568 for:    applied AND irritation

FS2 Safety and Tolerability Study in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02340325
Recruitment Status : Completed
First Posted : January 16, 2015
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Anthony Papp, British Columbia Professional Firefighters' Burn and Wound Healing Laboratory

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.


Condition or disease Intervention/treatment Phase
Cicatrix Cicatrix, Hypertrophic Keloid Drug: Acute Application of kynurenic acid cream Drug: Chronic application of kynurenic acid cream Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Safety of Topically Delivered FS2 in Humans. Phase 1 Clinical Trial
Study Start Date : May 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Scars

Arm Intervention/treatment
Acute Sensitivity Test to FS2 cream
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.
Drug: Acute Application of kynurenic acid cream
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.
Other Name: Fibrostop 2 (FS2)

Chronic Sensitivity Test to FS2 cream
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.
Drug: Chronic application of kynurenic acid cream
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
Other Name: Fibrostop 2 (FS2)




Primary Outcome Measures :
  1. Acute skin irritation or local reaction [ Time Frame: 24 hours ]
    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 :
  1. Chronic skin irritation or local reaction [ Time Frame: 1 month ]
    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

  2. Chronic exposure serum drug levels [ Time Frame: 30 days ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340325


Locations
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Canada, British Columbia
BCPFF Burn & Wound Healing Lab
Vancouver, British Columbia, Canada, V5Z1M9
Sponsors and Collaborators
British Columbia Professional Firefighters' Burn and Wound Healing Laboratory
Investigators
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Principal Investigator: Anthony Papp, MD BC Professional Fire Fighters' Burn and Wound Healing Laboratory

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Responsible Party: Anthony Papp, Medical Director, British Columbia Professional Firefighters' Burn and Wound Healing Laboratory
ClinicalTrials.gov Identifier: NCT02340325     History of Changes
Other Study ID Numbers: H14-00143
First Posted: January 16, 2015    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
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Hypertrophy
Cicatrix
Cicatrix, Hypertrophic
Pathological Conditions, Anatomical
Fibrosis
Pathologic Processes
Kynurenic Acid
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs