Restylane® Lyft Filler Injection for Hand Rejuvenation on First Impressions

Phase 1

Completed

• Conditions: Hand Rejuvination
• Interventions: Drug: Restylane® Lyft

• Registration Number: NCT04162002
• Lead Sponsor: DeNova Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-01
• Study Start: 2019-10-10
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-12
• Study First Posted: 2019-11-13
• Primary Completion: 2019-11-18
• Study Completion: 2019-11-18
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Restylane® Lyft Filler Injection	Restylane® Lyft	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

DeNova Research; 🇺🇸 Chicago, Illinois, United States