Clinical trial NCT02985437: Safety and Tolerability of Topically Applied Bovine Lung Surfactant on Intact Skin
Official title: Safety and Tolerability of Topically Applied Bovine Lung Surfactant on Intact Skin and Superficial Subepidermal Lesions in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin and Connective Tissue Diseases
Keywords: wound healing
Bovine Lung Surfactant
SATOSU
Lead sponsor: University of Bremen
Sponsor class: OTHER
Collaborators: name: European Research Council
First posted: 2016-12-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Tolerability of Lung Surfactant in cutaneous application measured by mean Clinical Scoring Scale for dermatitis (CSS) computed over all visits
timeFrame: days 2,4,6,8,10,12,14 post baseline
Secondary outcomes:
measure: Time to wound conclusion of wound healing and reepithelialisation: measurement of wound surface
timeFrame: up to 14 days and one time follow up after 30 days
measure: Pain measured by mean Visual Analogue Scale over all visits
timeFrame: days 2,4,6,8,10,12,14 post baseline
measure: TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
timeFrame: day 2
measure: TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
timeFrame: day 4
measure: TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
timeFrame: day 6
measure: TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
timeFrame: day 8
measure: TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
timeFrame: day 10
measure: TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
timeFrame: day 12
measure: TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
timeFrame: day 14
Other outcomes:
measure: Adverse Events
timeFrame: up to 14 days and one time follow up after 30 days
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: Baseline and day 14
Locations:
city: Bremen
country: Germany
facility: University of Bremen
Study officials:
affiliation: University of Bremen
name: Ursula Mirastschijski, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: