FS2 Safety and Tolerability Study in Healthy Volunteers

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: British Columbia Professional Firefighters' Burn and Wound Healing Laboratory
• Treatments: Kynurenic Acid

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.