Topical Application of Highly Concentrated Water-in-oil Emulsions

University of Vienna

Status: Completed

Conditions: Skin Physiology; Emulsions; Dermal Administration

Treatments: Other: Application of emulsion; Procedure: Tape stripping; Procedure: Measurement of physiological skin parameters

Study type: Interventional

Funder types: Other

Identifiers

NCT03876639

SkinStudy 2019.1

Details and patient eligibility

About

The purpose of this study is to I. determine the effect of repetitive application of newly developed silicone based formulations (placebo water-in-oil emulsions) on transepidermal water loss and other physiological skin parameters and II. investigate the skin penetration of the model drug fluorescein sodium in tape stripping studies to determine the in vivo penetration profile from the water-in-oil emulsions.

Full description

Water-in-oil emulsions will be applied daily for a period of 4 weeks on the non-dominant volar forearm of voluntary participants. Several physiological skin parameters will be monitored in weekly intervals during the application period. Additional measurements will be carried out immediately before the start of the application and after a treatment-free recovery period of 2 weeks. The untreated forearm will be used as a reference.

Subsequent to the observational study, tape stripping experiments with fluorescein sodium-loaded formulations will be conducted on the non-dominant forearm of the participants.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of subject informed consent
• Female or male aged between 18 and 65 years

Exclusion criteria

• Pregnancy
• Chronic skin conditions

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

IPM_2/18

Active Comparator group

Description:

Application of formulation IPM_2/18

Treatment:

Procedure: Tape stripping

Other: Application of emulsion

Procedure: Measurement of physiological skin parameters

PAR_2/18

Active Comparator group

Description:

Application of formulation PAR_2/18

Treatment:

Procedure: Tape stripping

Other: Application of emulsion

Procedure: Measurement of physiological skin parameters