Restylane® Lyft Filler Injection for Hand Rejuvenation on First Impressions

NCT04162002 | Completed Phase 1 FDA Drug

• 1 other identifier: REST- HAN-2019
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Rejuvination

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Restylane® Lyft Filler Injection

EXPERIMENTAL

Drug: Restylane® Lyft

Interventions

Restylane® Lyft DRUG

Filler Injection

Restylane® Lyft Filler Injection

Eligibility Criteria

• Age: 28 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• Males and females below age of 28.
• 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. -

Sponsors & Collaborators

• DeNova Research: lead
• Galderma R&D: collaborator

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

Study Officials

• Steven Dayan, MD

  DeNova Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Assistant Professor

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: November 13, 2019
• Study Start: October 10, 2019
• Primary Completion: November 18, 2019
• Study Completion: November 18, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11

Locations

US (1)