Overview

This trial is active, not recruiting.

Condition volume deficit in the hand
Treatment restylane lyft with lidocaine
Sponsor Q-Med AB
Start date December 2015
End date October 2016
Trial size 120 participants
Trial identifier NCT02650921, 43USH1501

Summary

This is a randomized, evaluator-blind, split hand, multi-center study of the effectiveness and safety or Restylane Lyft with Lidocaine compared to no treatment for injection in the dorsal hand to correct volume deficits.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
restylane lyft with lidocaine
An injectable gel of Hyaluronic Acid and Lidocaine
(No Intervention)

Primary Outcomes

Measure
Change from Baseline using validated scale at 12 Weeks
time frame: 12 Weeks

Eligibility Criteria

Male or female participants at least 22 years old.

Key Inclusion Criteria: - Subjects willing to comply with the requirements of the study and providing a signed written informed consent including release of copyright of hand images. - Males or females, 22 years of age or older - Willing and able to perform hand functionality tests . Key Exclusion Criteria: - History of allergy or hypersensitivity to injectable HA gel or to gram positive bacterial proteins. - History of allergy or hypersensitivity to lidocaine or other amide type anesthetics. - Previous hand surgery including sclerotherapy, or history of hand trauma. - Advanced photo aged/ photo damaged skin or skin condition with very crinkled or fragile skin on the dorsal hands.

Additional Information

Official title A Randomized, Evaluator Blinded, Split-hand Study to Evaluate the Effectiveness and Safety of Restylane Lyft With Lidocaine Compared to no Treatment for Injection in the Dorsal Hand to Correct Volume Deficit
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Q-Med AB.