NCT02985437

Safety and Tolerability of Topically Applied Bovine Lung Surfactant on Intact Skin

Safety and Tolerability of Topically Applied Bovine Lung Surfactant on Intact Skin and Superficial Subepidermal Lesions in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Prof. Dr. Dr. Ursula Mirastschijski · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Bovine Lung Surfactant is used as standard therapy for reducing alveolar surface tension in preterm infants. Here the drug is administered via airways. The use on skin to stimulate the wound healing has not yet been tested in humans, i.e. it is not yet approved for the treatment of wound healing disorders. In the planned clinical trial Lung Surfactant is used the first time for the local treatment of skin lesions in humans. No substance related side effects were observed during the application via airways in neonates. The innovative idea to use lung surfactant for skin wound healing derived from two observations. First, when the skin is injured, the barrier protecting the moist body surface from the dry environment is discontinued and in part lost. Lung surfactant has several characteristics that might be beneficial for treatment of chronic cutaneous wounds.

Conditions

• Skin and Connective Tissue Diseases

Interventions

Type	Name	Description
DRUG	Surfactants
DRUG	Saline Solution

Timeline

• Start date: 2016-12-08
• Primary completion: 2017-08-30
• Completion: 2017-08-30
• First posted: 2016-12-07
• Last updated: 2017-09-07

Locations

1 site across 1 country: Germany