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Clinical Trials/NCT04162002
NCT04162002
Completed
Phase 1

Effects of Restylane® Lyft Filler Injection for Hand Rejuvenation on First Impressions

DeNova Research1 site in 1 country10 target enrollmentStarted: October 10, 2019Last updated:

Overview

Phase
Phase 1
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
The effects of Restylane® Lyft Filler injection into the dorsal hand on first impressions.

Overview

Brief Summary

The purpose of this research is to determine the effects of Restylane® Lyft Filler injection into the back of the hand on first impressions.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
28 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Males and females of ages 28 and above.
  • Subjects will be required not to have had previous filler fat injections, or other cosmetic treatments to their hands within the last 12 months.
  • Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visit. -

Exclusion Criteria

  • Males and females below age of
  • Subjects who have had previous filler, fat injections, or other cosmetic treatments to their hands within the last 12 months.
  • Subjects who are pregnant or nursing.
  • Subjects with a known allergy or sensitivity to any component of the study ingredients.
  • Any history of bleeding disorders (iatrogenic or otherwise). This includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
  • Anyone taking aspirin, ibuprofen, St. John's Wort, or high doses of Vitamin E supplements in the last 3 weeks.
  • Subjects with diseases, injuries, or disabilities of the hand, including those with autoimmune disease affecting the hand, hand implants, Dupuytren's contracture, history of hand tumor, vascular malformations, Raynaud's disease and patients at risk for tendon rupture.
  • Subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required treatment and follow up visit will also be excluded. -

Arms & Interventions

Restylane® Lyft Filler Injection

Experimental

Intervention: Restylane® Lyft (Drug)

Outcomes

Primary Outcomes

The effects of Restylane® Lyft Filler injection into the dorsal hand on first impressions.

Time Frame: 4 weeks

Subjects will have a picture of their hand evaluated by third party physicians on the basis of: Social Skills Positive mood, gets along with others well, friendly 1-10 rating Academic Performance Intelligent, highly educated, received good grades in school 1-10 rating Dating Success Dates frequently, lacks dating anxiety 1-10 rating Occupational Success Good worker, competent, motivated for success, suitable as potential employee 1-10 rating Attractiveness Pleasing appearance 1-10 rating Financial Success Has achieved financial success, member of a high social class 1-10 rating Relationship Success Willingness to compromise, ability to maintain long term friendships 1-10 rating Athletic Success Excels at athletic skills, plays individual and/or team sports 1-10 rating

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Steven H. Dayan

Principal Investigator, Clinical Assistant Professor

University of Illinois at Chicago

Study Sites (1)

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