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Restylane® Lyft Filler Injection for Hand Rejuvenation on First Impressions

D

DeNova Research

Status and phase

Completed
Phase 1

Conditions

Hand Rejuvination

Treatments

Drug: Restylane® Lyft

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04162002
REST- HAN-2019

Details and patient eligibility

About

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

Enrollment

10 patients

Sex

All

Ages

28+ years old

Volunteers

Accepts Healthy Volunteers

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. -

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Restylane® Lyft Filler Injection
Experimental group
Treatment:
Drug: Restylane® Lyft

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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