A Phase 1 interventional study of Surfactants and Saline Solution in Skin and Connective Tissue Diseases, sponsored by Prof. Dr. Dr. Ursula Mirastschijski. Completed at 1 site in Germany. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-07.
Sponsored by Prof. Dr. Dr. Ursula Mirastschijski · Phase 1, Interventional, and Treatment
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.
150 studies on the registry are indexed under Connective Tissue Diseases; 60 are open to participants now.
This study's enrollment of 24 is below the median of 98 across 99 interventional studies indexed under Connective Tissue Diseases.
Browse Connective Tissue Diseases studies →This is the only study on the registry with Prof. Dr. Dr. Ursula Mirastschijski as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Alveofact® (Bovine Lung Surfactant), 0.5 mg/ml per day (solution) all two days maximal eight times
Drug: Surfactants
0.9% Sodium chloride solution (NaCl solution), 2 ml per day (solution) all two days maximal eight times
Drug: Saline Solution
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
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
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time frame: day 2
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time frame: day 4
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time frame: day 6
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time frame: day 8
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time frame: day 10
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time frame: day 12
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time frame: day 14
Adverse Events
Time frame: up to 14 days and one time follow up after 30 days
Number of Participants With Abnormal Laboratory Values
Time frame: Baseline and day 14
Plan to share: No
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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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