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Restylane Silk for Photoaged Thinned Hands

S

Skin Laser & Surgery Specialists

Status

Completed

Conditions

Photoaged Thinning of the Hands

Treatments

Device: Restylane Silk

Study type

Interventional

Funder types

Other

Identifiers

NCT02780258
RESTHANDS01

Details and patient eligibility

About

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

Enrollment

25 patients

Sex

Female

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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