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

Study Overview
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Brief Summary
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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.

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

Conditions
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Skin and Connective Tissue Diseases

Intervention / Treatment
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* Drug: Surfactants
* Drug: Saline Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surfactant<br>Alveofact® (Bovine Lung Surfactant), 0.5 mg/ml per day (solution) all two days maximal eight times | Drug: Surfactants<br> <br> |
| Active Comparator: Saline<br>0.9% Sodium chloride solution (NaCl solution), 2 ml per day (solution) all two days maximal eight times | Drug: Saline Solution<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of Lung Surfactant in cutaneous application measured by mean Clinical Scoring Scale for dermatitis (CSS) computed over all visits |  | days 2,4,6,8,10,12,14 post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to wound conclusion of wound healing and reepithelialisation: measurement of wound surface |  | up to 14 days and one time follow up after 30 days | 
| Pain measured by mean Visual Analogue Scale over all visits |  | days 2,4,6,8,10,12,14 post baseline | 
| TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure |  | day 2 | 
| TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure |  | day 4 | 
| TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure |  | day 6 | 
| TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure |  | day 8 | 
| TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure |  | day 10 | 
| TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure |  | day 12 | 
| TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure |  | day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound healing, Bovine Lung Surfactant, SATOSU