Healthy Subjects
Conditions
Interventions
Group 1: Subjects will place one arm in a hand bath with warm water containing the base composition bath salt for 30 min on 2 consecutive days. Demographics and Medical History will be assessed at bas
Sponsors
Alexander Weltecke GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Male or female aged = 18 years on the day of screening 2) Subjects able to understand the informed consent and willing to participate as evidenced by providing informed consent. 3) Signed Informed Consent 4) Subjects able and willing to attend all scheduled visits and comply with all study procedures
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity to a component of the base composition bath salt 2) Open wounds 3) Active infections 4) Severe generalized disease resulting in a life expectancy shorter than 3 months 5) Pregnant or breast-feeding women 6) Women of childbearing potential without effective contraception 7) Alcohol- or drug abuse 8) Subjects with psychiatric disorders influencing their judgement or autonomy 9) Inability or unwillingness to understand or comply with required study procedures 10) Subjects who are not suitable for the study based on the principal investigator’s evaluation 11) Subjects who are financially or otherwise dependent on the principal investigator or sponsor. 12) Subjects who are imprisoned or have been institutionalized for medical reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness - Increase in wellbeing will be assessed with a questionnaire before and after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety- Safety will be assessed by measuring the incidence and prevalence of adverse events throughout the study. Effectiveness- Skin smoothness will be assessed before and after treatment by visual assessment and measured using a Sebumeter® Transepidermal water loss (TEWL) will be measured before and after treatment using a Tewameter® Skin pH will be measured before and after treatment using a skin pH meter | — |
Countries
Germany
Contacts
Public ContactEva Kristina Bee
Praxis für Hautkrankheiten Dr. med. Eva Kristina Bee
Outcome results
None listed