This trial is active, not recruiting.

Condition dorsal hands
Treatment restylane vital
Sponsor Q-Med AB
Start date October 2015
End date April 2016
Trial size 109 participants
Trial identifier NCT02545608, 43CH1406


The purpose of this study is to determine the safety and efficacy of using Restylane Vital for skin rejuvenation of the dorsal hands. Assessment of improvement of skin structure will be done by a blinded evaluator.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Restylane Vital in one of the hands
restylane vital
(No Intervention)
No treatment in the other hand.

Primary Outcomes

The efficacy of Restylane Vital on skin structure compared to no treatment using a validated scale.
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Signed Informed Consent - Chinese origin - Subject willing and able to comply with the requirements of the study and agrees to adhere to the visit schedule and to be compliant to the study instructions Exclusion Criteria: - Any previous non-permanent implant/filler in the hands - Any mesotherapy or resurfacing procedure in the hands within 6 months prior to baseline - Any previous hand surgery - Any fibrosis or scarring or deformities on the hands - Advanced photoaged/photodamaged skin

Additional Information

Official title A Randomised, Multi-centre, Evaluator-blinded, Split-hand, no Treatment-controlled Study to Evaluate the Safety and Efficacy of Restylane Vital for Skin Rejuvenation of the Dorsal Hands in Chinese Subjects
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Q-Med AB.