NCT05138107

Prospective Placebo-controlled Study of Synochi Scar Spray

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Synochi, LLC · Industry
• Sex: All
• Age: 22 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Randomized, double-blind, placebo controlled, prospective, split-scar study of severe burn victims with autologous skin transplants. 9 months intervention time and 3 months follow-up, photographic scar documentation, self-and observer questionnaires throughout

Detailed description

Interventional, comparative, prospective, evaluator blinded, randomized, placebo- controlled, split-scar model longitudinal study including 28-31 healthy study participants (See Section 6 Statistical Considerations) with both the original burn scar area that is the skin graft recipient area and the skin graft donor site.

Conditions

• Burns Multiple

Interventions

Type	Name	Description
OTHER	Synochi Scar Spray Cosmetic	Application of the cosmetic on each skin graft in a blinded fashion in different sections for a 9 month duration.
OTHER	Synochi Scar Spray Placebo	Application of the placebo on each skin graft in a blinded fashion in different sections for a 9 month duration.

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-05-17
• Completion: 2025-07-17
• First posted: 2021-11-30
• Last updated: 2022-06-16