Photoaged Thinning of the Hands
Conditions
Brief summary
To evaluate the safety and efficacy of Restylane Silk for photoaged thinned hands
Interventions
DEVICERestylane Silk
Sponsors
Skin Laser & Surgery Specialists
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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 |
Outcome results
None listed