UnknownNot Applicable

Restylane Silk Microinjections to Cheeks

United States20 participantsStarted 2019-02-26

Plain-language summary

The objective of this study is to determine the efficacy and safety of Restylane® Silk microinjections when used in a grid-like injection pattern for the correction of fine lines to the cheeks.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
✓. Intrauterine coil
✓. Bilateral tubal ligation
✓. Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
✓. Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).
✓. Vasectomized partner (must agree to use barrier method described above (4) if becomes sexually active with un-vasectomized).

Exclusion criteria

✕. Pregnant, planning pregnancy during the course of the study or breastfeeding
✕. Extremely Severe aging face with extensive photodamage
✕. Previous use of any form of soft tissue augmentation in the treatment area within the past 12 months
✕. Pre-existing medical or dermatologic condition in the treatment area that may affect the treatment or interpretation of treatment effect (at investigator discretion)
✕. Presence of tattoo and/or scar in the treatment area that in the investigators opinion would interfere with study assessments
✕. Use of oral/topical retinoids within 1 month of Baseline
✕. Previous use of botulinum toxins in the treatment area within the past 6 months
✕. Previous surgical procedure in the treatment area within the past 12 months

What they're measuring

Investigator five point global aesthetic improvement score

Timeframe: Baseline to 6 - Months Post Final Treatment

Cutometer Measured Skin Elaticity

Timeframe: Baseline to 6 - Months Post Final Treatment

Hydrometer measured Transepidermal Water Loss

Timeframe: Baseline to 6 - Months Post Final Treatment

Trial details

NCT IDNCT03742479

SponsorGoldman, Butterwick, Fitzpatrick and Groff

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

Contact for this trial

Shannon Quigley

858 657 1004 SQuigley@CLDerm.com

View on ClinicalTrials.gov More Wrinkle trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
✓. Intrauterine coil
✓. Bilateral tubal ligation
✓. Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
✓. Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).
✓. Vasectomized partner (must agree to use barrier method described above (4) if becomes sexually active with un-vasectomized).

Exclusion criteria

✕. Pregnant, planning pregnancy during the course of the study or breastfeeding
✕. Extremely Severe aging face with extensive photodamage
✕. Previous use of any form of soft tissue augmentation in the treatment area within the past 12 months
✕. Pre-existing medical or dermatologic condition in the treatment area that may affect the treatment or interpretation of treatment effect (at investigator discretion)
✕. Presence of tattoo and/or scar in the treatment area that in the investigators opinion would interfere with study assessments
✕. Use of oral/topical retinoids within 1 month of Baseline
✕. Previous use of botulinum toxins in the treatment area within the past 6 months
✕. Previous surgical procedure in the treatment area within the past 12 months

What they're measuring

Investigator five point global aesthetic improvement score

Timeframe: Baseline to 6 - Months Post Final Treatment

Cutometer Measured Skin Elaticity

Timeframe: Baseline to 6 - Months Post Final Treatment

Hydrometer measured Transepidermal Water Loss

Timeframe: Baseline to 6 - Months Post Final Treatment