Restylane Silk for Photoaged Thinned Hands
Not Applicable
Completed
- Conditions
- Photoaged Thinning of the Hands
- Registration Number
- NCT02780258
- Lead Sponsor
- Skin Laser & Surgery Specialists
- Brief Summary
To evaluate the safety and efficacy of Restylane Silk for photoaged thinned hands
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 25
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in photoaged thinning of the treatment area as measured by the 5 point hand grading scale Baseline, 1month, 3months, 6 months
- Secondary Outcome Measures
Name Time Method