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

Prof. Dr. Dr. Ursula Mirastschijski

Status and phase: Completed; Phase 1

Conditions: Skin and Connective Tissue Diseases

Treatments: Drug: Surfactants; Drug: Saline Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02985437

2015-000890-11 (EudraCT Number)

DRKS00011353 (Other Identifier)

SMWH01

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Surfactant

Experimental group

Description:

Alveofact® (Bovine Lung Surfactant), 0.5 mg/ml per day (solution) all two days maximal eight times

Treatment:

Drug: Surfactants

Saline

Active Comparator group

Description:

0.9% Sodium chloride solution (NaCl solution), 2 ml per day (solution) all two days maximal eight times

Treatment:

Drug: Saline Solution