Trial | NCT02985437  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    24
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.
Study Started
Dec 08
2016
Primary Completion
Aug 30
2017
Study Completion
Aug 30
2017
Last Update
Sep 07
2017

Drug Surfactants

Drug Saline Solution

Surfactant Experimental

Alveofact® (Bovine Lung Surfactant), 0.5 mg/ml per day (solution) all two days maximal eight times

Saline Active Comparator

0.9% Sodium chloride solution (NaCl solution), 2 ml per day (solution) all two days maximal eight times

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
No Results Posted