Restylane Silk for Photoaged Thinned Hands

To evaluate the safety and efficacy of Restylane Silk for photoaged thinned hands

Study Overview

• Status: Completed
• Conditions: Photoaged Thinning of the Hands
• Intervention / Treatment: Device: Restylane Silk

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female volunteer
• Aged from 40-70 years on the day of screening
• No known medical conditions that may interfere with study participation
• Moderate to very severe Photoaged thinning of the hands based on the 5-point hand grading scale
• Willingness to not use any products on their hands for the duration of the study
• Read, understand, and sign informed consent forms
• Willingness to sign photography release form
• Willing and able to comply with all follow-up requirements
• Willingness to undergo Restylane Silk injections to one hand

Exclusion Criteria:

• Any significant skin disease at treatment area
• Any medical condition which could interfere with the treatment
• Inability or unwillingness to follow the treatment schedule
• Inability or unwillingness to sign the informed consent
• History of poor wound healing
• History of keloid formation
• History of HIV, hepatitis, immuno-compromised
• Pregnant or lactating
• Previous use of deep chemical peels on the treatment area
• Previous injections of Restylane Silk to the hands
• Known hypersensitivity to Restylane Silk or any of its ingredients
• Previous laser or light based treatments to the treatment area 6 months prior to the screening visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Restylane Silk Treated Hand; The dorsal aspect of one hand will be injected with Restylane Silk.	Device: Restylane Silk
No Intervention: Control Hand; The dorsal aspect of the hand that is not treated will be used for baseline comparison.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in photoaged thinning of the treatment area as measured by the 5 point hand grading scale	Baseline, 1month, 3months, 6 months

Collaborators and Investigators

• Sponsor: Skin Laser & Surgery Specialists

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2015
• Primary Completion (Actual): October 28, 2016
• Study Completion (Actual): October 28, 2016

Study Registration Dates

• First Submitted: May 19, 2016
• First Submitted That Met QC Criteria: May 20, 2016
• First Posted (Estimate): May 23, 2016

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: RESTHANDS01