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

Prof. Dr. Dr. Ursula Mirastschijski24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin and Connective Tissue Diseases

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Two healthy forearms, * No known chronical skin diseases, * Dermatoses or allergies, * Signed form of consent, * Caucasian Exclusion Criteria: * Pregnancy or nursing period, * Diabetes (Type I or II), * Systemic or infectious diseases, * Skin disease, * Known allergies against bovine products or wound dressings, * Mental diseases, missing ability to consent, * Addictive disorders (e.g. alcohol, drugs), * Peripheral circulatory disorder, Morbus Raynaud, * Current (or \< 4 weeks ago) participation in clinical trials

Outcomes

Primary Outcomes

Tolerability of Lung Surfactant in cutaneous application measured by mean Clinical Scoring Scale for dermatitis (CSS) computed over all visits

Time frame: days 2,4,6,8,10,12,14 post baseline

Secondary Outcomes

Time to wound conclusion of wound healing and reepithelialisation: measurement of wound surface

Time frame: up to 14 days and one time follow up after 30 days

Pain measured by mean Visual Analogue Scale over all visits

Time frame: days 2,4,6,8,10,12,14 post baseline