Safety and Tolerability of Topically Applied Bovine Lung Surfactant on Intact Skin (SATOSU)
Primary Purpose
Skin and Connective Tissue Diseases
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Surfactants
Saline Solution
Sponsored by
About this trial
This is an interventional treatment trial for Skin and Connective Tissue Diseases focused on measuring wound healing, Bovine Lung Surfactant, SATOSU
Eligibility Criteria
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
Sites / Locations
- University of Bremen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Surfactant
Saline
Arm Description
Alveofact® (Bovine Lung Surfactant), 0.5 mg/ml per day (solution) all two days maximal eight times
0.9% Sodium chloride solution (NaCl solution), 2 ml per day (solution) all two days maximal eight times
Outcomes
Primary Outcome Measures
Tolerability of Lung Surfactant in cutaneous application measured by mean Clinical Scoring Scale for dermatitis (CSS) computed over all visits
Secondary Outcome Measures
Time to wound conclusion of wound healing and reepithelialisation: measurement of wound surface
Pain measured by mean Visual Analogue Scale over all visits
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Full Information
NCT ID
NCT02985437
First Posted
November 28, 2016
Last Updated
September 6, 2017
Sponsor
Prof. Dr. Dr. Ursula Mirastschijski
Collaborators
European Research Council
1. Study Identification
Unique Protocol Identification Number
NCT02985437
Brief Title
Safety and Tolerability of Topically Applied Bovine Lung Surfactant on Intact Skin
Acronym
SATOSU
Official Title
Safety and Tolerability of Topically Applied Bovine Lung Surfactant on Intact Skin and Superficial Subepidermal Lesions in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
December 8, 2016 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
August 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. Dr. Ursula Mirastschijski
Collaborators
European Research Council
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin and Connective Tissue Diseases
Keywords
wound healing, Bovine Lung Surfactant, SATOSU
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surfactant
Arm Type
Experimental
Arm Description
Alveofact® (Bovine Lung Surfactant), 0.5 mg/ml per day (solution) all two days maximal eight times
Arm Title
Saline
Arm Type
Active Comparator
Arm Description
0.9% Sodium chloride solution (NaCl solution), 2 ml per day (solution) all two days maximal eight times
Intervention Type
Drug
Intervention Name(s)
Surfactants
Intervention Type
Drug
Intervention Name(s)
Saline Solution
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Pain measured by mean Visual Analogue Scale over all visits
Time Frame
days 2,4,6,8,10,12,14 post baseline
Title
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time Frame
day 2
Title
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time Frame
day 4
Title
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time Frame
day 6
Title
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time Frame
day 8
Title
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time Frame
day 10
Title
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time Frame
day 12
Title
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time Frame
day 14
Other Pre-specified Outcome Measures:
Title
Adverse Events
Time Frame
up to 14 days and one time follow up after 30 days
Title
Number of Participants With Abnormal Laboratory Values
Time Frame
Baseline and day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Mirastschijski, Prof. Dr.
Organizational Affiliation
University of Bremen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bremen
City
Bremen
ZIP/Postal Code
28359
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Tolerability of Topically Applied Bovine Lung Surfactant on Intact Skin
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