ClinicalTrials.gg
CompletedNCT03494140Updated Sep 18, 2018

Viscontour® Serum Med in Hydration of Facial Skin

An observational study in Sodium Hyaluronate, sponsored by TRB Chemedica AG. Completed at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-18.

Sponsored by TRB Chemedica AG · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
Female
01

Study summary

The objective of this study is to confirm the clinical safety and efficacy of Viscontour® Serum Med in the hydration of facial tissue.

02

Conditions studied

  • Sodium Hyaluronate
03

In context

Lead sponsor

TRB Chemedica AG is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with a Viscontour® Serum Med therapy recommendation (i.a. for hydration, soothing, nourishing and refreshing the complexion and for use in combination with a day cream)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Females ≥ 18 years of age and in good general health condition
  2. Signed
  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

Exclusion Criteria:

  1. Known 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 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Interventions

  • DeviceViscontour® Serum Med

    Viscontour® Serum Med is a CE-certified preservative-free isotonic solution containing 5.0 mg sodium hyaluronate.

06

What researchers measure

Primary outcomes

  1. Change of Skin Parameters compared to Baseline

    Routine Evaluation of the Overall Skin Condition

    Time frame: 20 Minutes, Day 7 and Day 28

  2. Change of Subjective Therapy Evaluation (Questionnaire) compared to Baseline

    Time frame: 20 Minutes, Day 7 and Day 28

  3. Incidence of Treatment-Emergent Adverse Events

    Time frame: Up to Day 28

07

Study locations

1 site
  • Praxis Dr. Dirk Gröne
    Berlin, 14052, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03494140
Lead sponsor
TRB Chemedica AG
Responsible party
Sponsor
First posted
Apr 11, 2018
Start date
Apr 18, 2018
Primary completion
Aug 18, 2018
Completion
Aug 18, 2018
Last update
Sep 18, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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