FS2 Safety and Tolerability Study in Healthy Volunteers

NCT02340325 | Completed Phase 1

• 1 other identifier: H14-00143
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cicatrix; Cicatrix, Hypertrophic; Keloid

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Secondary Outcomes (2)

• Chronic skin irritation or local reaction

  1 month

• Chronic exposure serum drug levels

  30 days

Study Arms (2)

Acute Sensitivity Test to FS2 cream

OTHER

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

Chronic Sensitivity Test to FS2 cream

OTHER

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

Interventions

Acute Application of kynurenic acid cream DRUG

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.

Also known as: Fibrostop 2 (FS2)

Acute Sensitivity Test to FS2 cream

Chronic application of kynurenic acid cream DRUG

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

Also known as: Fibrostop 2 (FS2)

Chronic Sensitivity Test to FS2 cream

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• British Columbia Professional Firefighters' Burn and Wound Healing Laboratory: lead

Study Sites (1)

BCPFF Burn & Wound Healing Lab

Vancouver, British Columbia, V5Z1M9, Canada

Location

MeSH Terms

Conditions

Cicatrix; Cicatrix, Hypertrophic; Keloid

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anthony Papp, MD

  BC Professional Fire Fighters' Burn and Wound Healing Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: January 16, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 2, 2016

Record last verified: 2016-02

Locations

CA (1)