Sodium Hyaluronate
Conditions
Brief summary
The objective of this study is to confirm the clinical safety and efficacy of Viscontour® Serum Med in the hydration of facial tissue.
Interventions
DEVICEViscontour® Serum Med
Viscontour® Serum Med is a CE-certified preservative-free isotonic solution containing 5.0 mg sodium hyaluronate.
Sponsors
TRB Chemedica AG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Females ≥ 18 years of age and in good general health condition 2. Signed informed consent 3. Existing Viscontour® Serum Med recommendation (i.a. for hydration, soothing, nourishing and refreshing the complexion and for use in combination with a day cream)
Exclusion criteria
1. Known hypersensitivity to one of the Viscontour® Serum Med components 2. Known pregnancy or lactating females 3. Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts 4. Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Skin Parameters compared to Baseline | 20 Minutes, Day 7 and Day 28 | Routine Evaluation of the Overall Skin Condition |
| Change of Subjective Therapy Evaluation (Questionnaire) compared to Baseline | 20 Minutes, Day 7 and Day 28 | — |
| Incidence of Treatment-Emergent Adverse Events | Up to Day 28 | — |
Countries
Germany
Outcome results
None listed