Viscontour® Serum Med in Hydration of Facial Skin

September 17, 2018 updated by: TRB Chemedica AG
The objective of this study is to confirm the clinical safety and efficacy of Viscontour® Serum Med in the hydration of facial tissue.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14052
        • Praxis Dr. Dirk Gröne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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)

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Skin Parameters compared to Baseline
Time Frame: 20 Minutes, Day 7 and Day 28
Routine Evaluation of the Overall Skin Condition
20 Minutes, Day 7 and Day 28
Change of Subjective Therapy Evaluation (Questionnaire) compared to Baseline
Time Frame: 20 Minutes, Day 7 and Day 28
20 Minutes, Day 7 and Day 28
Incidence of Treatment-Emergent Adverse Events
Time Frame: Up to Day 28
Up to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TRB Chemedica AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2018

Primary Completion (Actual)

August 18, 2018

Study Completion (Actual)

August 18, 2018

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

April 3, 2018

First Posted (Actual)

April 11, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • VISCH-PMCF-DE-2016-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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