NCT Number: NCT02780258
Restylane Silk for Photoaged Thinned Hands
To evaluate the safety and efficacy of Restylane Silk for photoaged thinned hands
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Conditions
Age range
40 year–70 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Change in photoaged thinning of the treatment area as measured by the 5 point hand grading scale
Time frame: Baseline, 1month, 3months, 6 months
Sponsors and collaborators
Lead sponsor
Skin Laser & Surgery Specialists
Other
Registry information
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- May 23, 2016
- Registry last updated
- Apr 17, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.