Recruiting

Restylane Silk

Sponsor:

Goldman, Butterwick, Fitzpatrick and Groff

Code:

NCT03742479

Conditions

Wrinkle

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Restylane® Silk

Study Details

Brief 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.

Conditions

Wrinkle

Study ID

NCT03742479

Start date

Feb 26, 2019

Status verified date

May, 2019

Completion date

Feb, 2020

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

b. Symmetrical visible sign of aging involving at least a 9 cm2 area of the mid to low cheeks.

c. Must be willing to give and sign a HIPPA form, photo consent and informed consent form.

d. Must be willing to comply with study dosing and complete the entire course of the study.

e. Female patients will be either of non-childbearing potential defined as:

1. Having no uterus 2. No menses for at least 12 months. Or; (WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as:

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

f. Negative urine pregnancy test results Baseline prior to study entry (if applicable)

Exclusion Criteria:
1. Pregnant, planning pregnancy during the course of the study or breastfeeding
2. Extremely Severe aging face with extensive photodamage
3. Previous use of any form of soft tissue augmentation in the treatment area within the past 12 months
4. Pre-existing medical or dermatologic condition in the treatment area that may affect the treatment or interpretation of treatment effect (at investigator discretion)
5. Presence of tattoo and/or scar in the treatment area that in the investigators opinion would interfere with study assessments
6. Use of oral/topical retinoids within 1 month of Baseline
7. Previous use of botulinum toxins in the treatment area within the past 6 months
8. Previous surgical procedure in the treatment area within the past 12 months
9. Presence or evidence of any conditions that in the opinion of the investigator might impede the subject's ability to give consent or comply with protocol requirements.
10. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
11. History of non-compliance with clinical research protocols
12. Ablative laser resurfacing to on their face within 12 months
13. Non-ablative laser or light procedures to their face within the past 3 months
14. Known allergy to Restylane® Silk or any of its constituents

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hyaluronic Acid Microinjection

Interventions

Restylane® Silk

Injectable Hyaluronic Acid (HA)

Primary outcome measure

  • Investigator five point global aesthetic improvement score [ Time Frame: Baseline to 6 - Months Post Final Treatment ]
  • Cutometer Measured Skin Elaticity [ Time Frame: Baseline to 6 - Months Post Final Treatment ]
  • Hydrometer measured Transepidermal Water Loss [ Time Frame: Baseline to 6 - Months Post Final Treatment ]

Central Contacts and Locations

Central contacts

Locations

West Dermatology Research Center

Recruiting

San Diego, California, United States, 92121

Contacts

Principal Investigator:

Mitchel P Goldman, MD

More Information

Sponsor

Goldman, Butterwick, Fitzpatrick and Groff

Last update posted

May 3, 2019

Last verified

May, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Goldman, Butterwick, Fitzpatrick and Groff on 2019-05-03.