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OpenTrials
Completed

NCT Number: NCT02780258

Restylane Silk for Photoaged Thinned Hands

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

Completed

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Key information

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

Restylane Silk

Device

Primary outcomes

  1. 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.