NCT03494140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

April 18, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

4 months

First QC Date

March 26, 2018

Last Update Submit

September 17, 2018

Conditions

Sodium Hyaluronate

Outcome Measures

Primary Outcomes (3)

  • Change of Skin Parameters compared to Baseline

    Routine Evaluation of the Overall Skin Condition

    20 Minutes, Day 7 and Day 28

  • 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

Interventions

Viscontour® Serum MedDEVICE

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Praxis Dr. Dirk Gröne

Berlin, 14052, Germany

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 11, 2018

Study Start

April 18, 2018

Primary Completion

August 18, 2018

Study Completion

August 18, 2018

Last Updated

September 18, 2018

Record last verified: 2018-09

Locations

DE(1)