A prospective, open label, single arm post-market study to assess effectiveness and safety of the base composition bath salt („Basis-Zusammensetzung Badesalz) in healthy subjects
- Conditions
- Healthy Subjects
- Registration Number
- DRKS00017458
- Lead Sponsor
- Alexander Weltecke GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 51
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness -<br>Increase in wellbeing will be assessed with a questionnaire before and after treatment
- Secondary Outcome Measures
Name Time Method Safety-<br>Safety will be assessed by measuring the incidence and prevalence of adverse events throughout the study.<br>Effectiveness-<br>Skin smoothness will be assessed before and after treatment by visual assessment and measured using a Sebumeter®<br>Transepidermal water loss (TEWL) will be measured before and after treatment using a Tewameter®<br>Skin pH will be measured before and after treatment using a skin pH meter<br>