NCT02985437

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

December 8, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

September 7, 2017

Status Verified

September 1, 2017

Enrollment Period

9 months

First QC Date

November 28, 2016

Last Update Submit

September 6, 2017

Conditions

Skin and Connective Tissue Diseases

Keywords

wound healingBovine Lung SurfactantSATOSU

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

  • Pain measured by mean Visual Analogue Scale over all visits

    days 2,4,6,8,10,12,14 post baseline

  • TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure

    day 2

  • TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure

    day 4

  • TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure

    day 6

  • +4 more secondary outcomes

Other Outcomes (2)

  • Adverse Events

    up to 14 days and one time follow up after 30 days

  • Number of Participants With Abnormal Laboratory Values

    Baseline and day 14

Study Arms (2)

Surfactant

EXPERIMENTAL

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

Drug: Surfactants

Saline

ACTIVE COMPARATOR

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

Drug: Saline Solution

Interventions

SurfactantsDRUG
Surfactant
Saline SolutionDRUG
Saline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Two healthy forearms,
  • No known chronical skin diseases,
  • Dermatoses or allergies,
  • Signed form of consent,
  • Caucasian

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bremen

Bremen, 28359, Germany

Location

MeSH Terms

Conditions

Skin and Connective Tissue Diseases

Interventions

Surface-Active AgentsSaline Solution

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and UsesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ursula Mirastschijski, Prof. Dr.

    University of Bremen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 28, 2016

First Posted

December 7, 2016

Study Start

December 8, 2016

Primary Completion

August 30, 2017

Study Completion

August 30, 2017

Last Updated

September 7, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)