Clinical Trials Logo

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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04971200 - Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo Early Phase 1
Active, not recruiting NCT05525741 - Assessment of Circulating Fubctional Mitochondrias in Vitiligo Patients N/A
Completed NCT02379793 - Skin Irritation Test of LEO 80185 Gel in Healthy Japanese Subjects Phase 1
Completed NCT01093911 - Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE) Phase 1
Completed NCT00147511 - Time To Efficacy and Onset Of Action Of Linezolid Phase 4
Completed NCT02355639 - A Single-Centre Clinical Trial to Assess Steroid Induced Skin Atrophy on Healthy Skin Phase 1
Completed NCT01764594 - Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus Phase 1
Active, not recruiting NCT05185258 - Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study Phase 4
Not yet recruiting NCT06427889 - Treatment Effects of Two Pharmaceutical Skin Care Creams for Xerotic Feet Among Persons With Diabetes Phase 4
Completed NCT02518048 - A Psoriasis Plaque Test Trial With LEO 90100 Compared to Betesil® in Patients With Psoriasis Vulgaris Phase 2
Withdrawn NCT03196115 - Biomarker for Hyaline Fibromatosis Syndrome (BioHFS)
Completed NCT02416258 - A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123) Phase 2