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

Skin and Connective Tissue Diseases Clinical Trial

— SATOSU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985437
• Other study ID #: SMWH01
• Secondary ID: 2015-000890-11DR
• Status: Completed
• Phase: Phase 1
• First received: November 28, 2016
• Last updated: September 6, 2017
• Start date: December 8, 2016
• Est. completion date: August 30, 2017

Study information

• Verified date: September 2017
• Source: University of Bremen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Skin and Connective Tissue Diseases

Intervention

Drug:
• Surfactants

• Saline Solution

Locations

Country	Name	City	State
Germany	University of Bremen	Bremen

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Dr. Dr. Ursula Mirastschijski	European Research Council

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events		up to 14 days and one time follow up after 30 days
Other	Number of Participants With Abnormal Laboratory Values		Baseline and day 14
Primary	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	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
Secondary	Pain measured by mean Visual Analogue Scale over all visits		days 2,4,6,8,10,12,14 post baseline
Secondary	TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure		day 2
Secondary	TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure		day 4
Secondary	TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure		day 6
Secondary	TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure		day 8
Secondary	TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure		day 10
Secondary	TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure		day 12
Secondary	TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure		day 14