Skin and Connective Tissue DiseasesPhase 1SATOSUNCT02985437
Safety and Tolerability of Topically Applied Bovine Lung Surfactant on Intact Skin
A Phase 1 study testing Surfactants and Saline Solution in people with Skin and Connective Tissue Diseases, run by Prof. Dr. Dr. Ursula Mirastschijski at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin and Connective Tissue Diseases
- What is being tested?
- Surfactants and Saline Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 8 Dec 2016to 30 Aug 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Two healthy forearms,
- No known chronical skin diseases,
- Dermatoses or allergies,
- Signed form of consent,
- Caucasian
Who cannot join
- 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,
Show all 9Show fewer
- Addictive disorders (e.g. alcohol, drugs),
- Peripheral circulatory disorder, Morbus Raynaud,
- Current (or < 4 weeks ago) participation in clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Tolerability of Topically Applied Bovine Lung Surfactant on Intact Skin and Superficial Subepidermal Lesions in Healthy Volunteers
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.
Read more
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.
- Conditions
- Skin and Connective Tissue Diseases
- Being tested
- Surfactants, Saline Solution
- Keywords
- wound healing, Bovine Lung Surfactant, SATOSU
- Medical subject headings
- Skin and Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurfactantsDrug
Saline SolutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Surfactant | Experimental | Alveofact® (Bovine Lung Surfactant), 0.5 mg/ml per day (solution) all two days maximal eight times Receives: Drug: Surfactants |
| Saline | Active comparator | 0.9% Sodium chloride solution (NaCl solution), 2 ml per day (solution) all two days maximal eight times Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of Lung Surfactant in cutaneous application measured by mean Clinical Scoring Scale for dermatitis (CSS) computed over all visits
Measured: 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
Measured: up to 14 days and one time follow up after 30 days
Pain measured by mean Visual Analogue Scale over all visits
Measured: days 2,4,6,8,10,12,14 post baseline
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Measured: day 2
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Measured: day 4
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Measured: day 6
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Measured: day 8
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Measured: day 10
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Measured: day 12
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Measured: day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study start8 Dec 2016
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin and Connective Tissue DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Dr. Ursula Mirastschijski
- Sponsor type
- University, hospital or other
- Collaborators
- European Research Council
- Responsible party
- Sponsor-investigator, Prof. Dr. Dr. Ursula Mirastschijski, University of Bremen
- Investigators
- Ursula Mirastschijski, Prof. Dr., Principal investigator, University of Bremen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985437
- Sponsor's protocol ID
- SMWH01
- Other IDs
- 2015-000890-11, DRKS00011353, 2015
- Acronym
- SATOSU
- Status last verified
- Sep 2017
- First submitted
- 28 Nov 2016
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Topically Applied Bovine Lung Surfactant on Intact Skin and Superficial Subepidermal Lesions in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02985437
- Acronym / sponsor ID
- SATOSU / SMWH01
- Conditions
- Skin and Connective Tissue Diseases
- Keywords
- wound healing, Bovine Lung Surfactant, SATOSU
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Prof. Dr. Dr. Ursula MirastschijskiUniversity, hospital or other
- Collaborators
- European Research Council
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surfactant | Experimental | Drug: SurfactantsAlveofact® (Bovine Lung Surfactant), 0.5 mg/ml per day (solution) all two days maximal eight times |
| Saline | Active comparator | Drug: Saline Solution0.9% Sodium chloride solution (NaCl solution), 2 ml per day (solution) all two days maximal eight times |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Two healthy forearms,
- No known chronical skin diseases,
- Dermatoses or allergies,
- Signed form of consent,
- Caucasian
Key exclusion criteria (9 listed)
- Pregnancy or nursing period,
- Diabetes (Type I or II),
- Systemic or infectious diseases,
- Skin disease,
- Known allergies against bovine products or wound dressings,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surfactants | Drug | Surfactant |
| Saline Solution | Drug | Saline |
Primary outcome
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
9 secondary outcomes
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
Pain measured by mean Visual Analogue Scale over all visits
Time frame: days 2,4,6,8,10,12,14 post baseline
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time frame: day 2
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time frame: day 4
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time frame: day 6
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time frame: day 8
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time frame: day 10
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time frame: day 12
TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure
Time frame: day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ursula Mirastschijski, Prof. Dr. principal investigator
University of Bremen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Surfactants and Saline Solution in people with Skin and Connective Tissue Diseases, run by Prof. Dr. Dr. Ursula Mirastschijski at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.