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Completed

NCT Number: NCT02985437

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

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.

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Key information

Conditions

Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Bremen

Bremen, 28359, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surfactants

Drug

Saline Solution

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Pain measured by mean Visual Analogue Scale over all visits

    Time frame: days 2,4,6,8,10,12,14 post baseline

  3. TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure

    Time frame: day 2

  4. TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure

    Time frame: day 4

  5. TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure

    Time frame: day 6

  6. TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure

    Time frame: day 8

  7. TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure

    Time frame: day 10

  8. TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure

    Time frame: day 12

  9. TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure

    Time frame: day 14

Other outcomes

  1. Adverse Events

    Time frame: up to 14 days and one time follow up after 30 days

  2. Number of Participants With Abnormal Laboratory Values

    Time frame: Baseline and day 14

Sponsors and collaborators

Lead sponsor

Prof. Dr. Dr. Ursula Mirastschijski

Other

Collaborators

  • European Research Council

Registry information

Official study title

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

Acronym: SATOSU

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 7, 2016
Registry last updated
Sep 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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