Restylane® Lyft Filler Injection for Hand Rejuvenation on First Impressions

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

Sponsors

Lead Sponsor: DeNova Research

Collaborator: Galderma

Source 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.

Overall Status Completed
Start Date October 10, 2019
Completion Date November 18, 2019
Primary Completion Date November 18, 2019
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
The effects of Restylane® Lyft Filler injection into the dorsal hand on first impressions. 4 weeks
Enrollment 10
Condition
Intervention

Intervention Type: Drug

Intervention Name: Restylane® Lyft

Description: Filler Injection

Arm Group Label: Restylane® Lyft Filler Injection

Eligibility

Criteria:

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. -

Gender: All

Minimum Age: 28 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Steven Dayan, MD Principal Investigator DeNova Research
Location
Facility: DeNova Research
Location Countries

United States

Verification Date

November 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Illinois at Chicago

Investigator Full Name: Steven H. Dayan

Investigator Title: Principal Investigator, Clinical Assistant Professor

Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Restylane® Lyft Filler Injection

Type: Experimental

Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov