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OpenTrials
Completed

NCT Number: NCT03494140

Viscontour® Serum Med in Hydration of Facial Skin

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

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Key information

Conditions

Sodium Hyaluronate

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Praxis Dr. Dirk Gröne

Berlin, 14052, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females ≥ 18 years of age and in good general health condition
  • Signed informed consent
  • 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

  • Known hypersensitivity to one of the Viscontour® Serum Med components
  • Known pregnancy or lactating females
  • 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
  • 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)

Treatment and study plan

Viscontour® Serum Med

Device

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

TRB Chemedica AG

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 11, 2018
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.