Safety and Tolerability of topically applied Bovine Lung Surfactant on intact skin and Superficial subepidermal lesions in Healthy Volunteers

Safety and Tolerability of topically applied Bovine Lung Surfactant on intact skin and Superficial subepidermal lesions in Healthy Volunteers - The SATOSU- Trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011353

Enrollment

Registered

2016-11-22

Start date

2016-12-08

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MeSH C17 Skin and Connective Tissue Diseases MedDRA - Epidermal and dermal conditions (10014982) MedDRA - Skin and subcutaneous tissue disorders (10040785) healty subjects

Interventions

Group 1: Alveofact® (Bovine Lung Surfactant) on intact skin and superficial subepidermal lesions, 0.5 mg/ml per day (solution) all two days maximal eight times Group 2: 0.9% NaCl on intact skin and su

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Two healthy forearms, no known chronical skin diseases, dermatoses or allergies, Signed form of consent, Caucasian

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Tolerability of Lung Surfactant in cutanous application measured by Clinical Scoring Scale for dermatitis(CSS), nine times (8 times every two days and one time follow up after 30 days)	—

Secondary

Measure	Time frame
Time to wound conclusion of wound healing and reepithelialisation: measurement of wound surface, pain measured by Visual Analogue Scale, TransEpidermal Water Loss = indirect measurement of reepithelialisation and of wound closure nine times (8 times every two days and one time follow up after 30 days)	—

Countries

Germany

Contacts

Public ContactMaike Kaluscha

Kompetenzzentrum für Klinische Studien Bremen Universität Bremen

kaluscha@math.uni-bremen.de+49 421 218 63788

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026