Restylane® Lyft Filler Injection for Hand Rejuvenation on First Impressions

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

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 Overview

• Status: Completed
• Conditions: Hand Rejuvination
• Intervention / Treatment: Drug: Restylane® Lyft

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males and females of ages 28 and above.
2. Subjects will be required not to have had previous filler fat injections, or other cosmetic treatments to their hands within the last 12 months.
3. 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:

1. Males and females below age of 28.
2. Subjects who have had previous filler, fat injections, or other cosmetic treatments to their hands within the last 12 months.
3. Subjects who are pregnant or nursing.
4. Subjects with a known allergy or sensitivity to any component of the study ingredients.
5. 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.
6. Anyone taking aspirin, ibuprofen, St. John's Wort, or high doses of Vitamin E supplements in the last 3 weeks.
7. 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.
8. 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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Restylane® Lyft Filler Injection	Drug: Restylane® Lyft; Filler Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effects of Restylane® Lyft Filler injection into the dorsal hand on first impressions.	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	4 weeks

Collaborators and Investigators

• Sponsor: DeNova Research
• Collaborators: Galderma R&D

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2019
• Primary Completion (ACTUAL): November 18, 2019
• Study Completion (ACTUAL): November 18, 2019

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (ACTUAL): November 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: REST- HAN-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes