Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Viscontour® Serum Med in Hydration of Facial Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494140
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
TRB Chemedica AG

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.

Condition or disease Intervention/treatment
Sodium Hyaluronate Device: Viscontour® Serum Med

Layout table for study information
Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Viscontour® Serum Med in Hydration of Facial Skin
Actual Study Start Date : April 18, 2018
Actual Primary Completion Date : August 18, 2018
Actual Study Completion Date : August 18, 2018

Intervention Details:
  • Device: Viscontour® Serum Med
    Viscontour® Serum Med is a CE-certified preservative-free isotonic solution containing 5.0 mg sodium hyaluronate.


Primary Outcome Measures :
  1. Change of Skin Parameters compared to Baseline [ Time Frame: 20 Minutes, Day 7 and Day 28 ]
    Routine Evaluation of the Overall Skin Condition

  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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)
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494140


Locations
Layout table for location information
Germany
Praxis Dr. Dirk Gröne
Berlin, Germany, 14052
Sponsors and Collaborators
TRB Chemedica AG
Layout table for additonal information
Responsible Party: TRB Chemedica AG
ClinicalTrials.gov Identifier: NCT03494140    
Other Study ID Numbers: VISCH-PMCF-DE-2016-09
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No