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

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

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 Overview

• Status: Completed
• Conditions: Skin and Connective Tissue Diseases
• Intervention / Treatment: Drug: Surfactants; Drug: Saline Solution

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Bremen, Germany, 28359
    • University of Bremen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
Adverse Events	up to 14 days and one time follow up after 30 days
Number of Participants With Abnormal Laboratory Values	Baseline and day 14

Collaborators and Investigators

• Sponsor: Prof. Dr. Dr. Ursula Mirastschijski
• Collaborators: European Research Council
• Investigators: Principal Investigator: Ursula Mirastschijski, Prof. Dr., University of Bremen

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2016
• Primary Completion (Actual): August 30, 2017
• Study Completion (Actual): August 30, 2017

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: December 2, 2016
• First Posted (Estimate): December 7, 2016

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: wound healing; Bovine Lung Surfactant; SATOSU
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: SMWH01; 2015-000890-11 (EudraCT Number); DRKS00011353 (Other Identifier: German Clinical Trials Register (DRKS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No