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

NCT02985437 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-09-07

No results posted yet for this study

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

DRUG

Surfactants

DRUG

Saline Solution

Sponsors & Collaborators

Principal Investigators

  • Ursula Mirastschijski, Prof. Dr. · University of Bremen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-08
Primary Completion
2017-08-30
Completion
2017-08-30

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02985437 on ClinicalTrials.gov