Restylane Silk for Photoaged Thinned Hands

NCT02780258 | Completed

• 1 other identifier: RESTHANDS01
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Photoaged Thinning of the Hands

Outcome Measures

Primary Outcomes (1)

• Change in photoaged thinning of the treatment area as measured by the 5 point hand grading scale

  Baseline, 1month, 3months, 6 months

Study Arms (2)

Restylane Silk Treated Hand

EXPERIMENTAL

The dorsal aspect of one hand will be injected with Restylane Silk.

Device: Restylane Silk

Control Hand

NO INTERVENTION

The dorsal aspect of the hand that is not treated will be used for baseline comparison.

Interventions

Restylane Silk DEVICE

Restylane Silk Treated Hand

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Skin Laser & Surgery Specialists: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David J. Goldberg, MD, JD

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 23, 2016
• Study Start: October 20, 2015
• Primary Completion: October 28, 2016
• Study Completion: October 28, 2016
• Last Updated: April 17, 2018

Record last verified: 2018-04