Clinical Safety and Scar Prevention Study of a Topical Antifibrotic Compound FS2.

• Status: Recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will investigate the safety and effectiveness of daily post surgical scar management, using a moisture-balancing base product containing different amounts of a novel (NCE) antifibrogenic compound FS2, a natural metabolite of the kynurenine pathway. Results of recent peer-reviewed, pre-clinical evidence warrant further investigation to validate therapeutic scar preventive efficacy of topically administered/delivered FS2. There are no known safety concerns with current product formulations. Recent Phase I clinical safety and tolerability data further support continuation of the research proposed in this study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of British Columbia

Criteria

Inclusion Criteria:

1. Medically able to consent to study requirements

2. Adult, male and female trauma patients

3. Ages 18 to 65 years of age

4. Fluent in English (able to consent without a translator)

5. Isolated skin wound of 3% Total Body Surface Area

6. Participant requires partial thickness skin graft (meshed/non-meshed), face and genitalia excluded.

7. Grafted skin is between 100 cm2 and 600 cm2

8. Maximum skin graft expansion ratio is 1:1.5

Exclusion Criteria:

1. Medically unable to consent to study requirements

2. Require an English translator to lawfully consent to the study and its requirements

3. Treatment sights (skin graft sights) located on the face and genitalia

4. Expected to be medically unstable for the duration of the study period and an additional 1-month thereafter

5. Pregnant, or attempting to become pregnant

6. Known immunosuppression or immunosuppressive illness

7. Subjects who had taken part in a clinical trial within 3 months prior to admission to this trial or who are currently participating in a clinical trial, whether an investigational drug was used or not.

8. Subjects who had any clinical evidence of severe ongoing or prolonged depression or mental illness

9. Subjects who smoke more than 20 cigarettes a day

10. Subjects who demonstrated evidence of drug abuse

11. Any other diagnosis, condition, physical or geographical limitation with the participant that may render, or increases the likelihood of rendering, him/her unable to complete the entire study.