Restylane Silk for Treatment of Chest Wrinkles

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Wrinkle

In brief

The purpose of this study is to assess the safety and efficacy of using Restylane Silk to reduce the appearance of photoaging on the chest. Restylane Silk is a temporary hyaluronic acid filler currently approved for the lips and fine lines around the mouth. This study will compare the appearance of chest wrinkles on half the chest treated with Restylane Silk and the other half, which will be treated with placebo.

Key facts

Study ID: NCT03324997
Run by: Heidi Waldorf
People needed: 0
Starts: 2018-01-28
Expected to finish: 2018-01-28
Last updated by the study team: 2018-03-06

Who can join

Age: 25 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Female patients between the ages of 25-55 years.
Moderate photodamaged skin of the chest/décolletage, as per the Fabi-Bolton chest wrinkle scale
Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods and able to comply with all study requirements including daily applications of the study product, and restrictions regarding concomitant medication and other treatments.
Female subject of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 30 days before Day 0 and at least 6 months after the last study product administration. Acceptable methods of birth control include intrauterine device (IUD); oral, transdermal, implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence and barrier methods with spermicide. Otherwise, if not of childbearing potential, subjects must: have a sterile or vasectomized partner; have had a hysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year.

You may not qualify if…

History of keloid or hypertrophic scarring
History of allergy or hypersensitivity to injectable hyaluronic acid gel, lidocaine, local topical anesthetics or nerve blocking agents
Presence of any of the following at treatment sites: active inflammation/dermatitis, infection, psoriasis, herpes zoster, acanthosis, cancer, precancer, actinic keratosis
History of the use of any other rejuvenate treatment in the preceding eight months or plans to use these substances or have these procedures during the study (including but not limited to neuromodulators, soft tissue augmentation, fractional resurfacing, chemical peel, ultrasound)
The use of daily platelet inhibiting agents (i.e. Aspirin), anti-inflammatory medications, anticoagulants, Vitamin E, ginkgo biloba and other "herbs / homeopathic remedies" within 7 days of before or after treatment.
History of severe allergies or multiple allergies manifested by Premarket Approval (PMA) P040024/s072: FDA Summary of Safety and Effectiveness Data page 10 anaphylaxis or a history of a hypotensive crisis in response to radio-contrast media or other osmotic agent
Presence of any condition, which in the opinion of the investigator, would make the subject unable to complete the study per protocol
Current use of immunosuppressive therapy
History of connective tissue diseases such as rheumatoid arthritis, systemic lupus erythematous, polymyositis, dermatomyositis, or scleroderma;
Participation in any interventional clinical research study within 30 days prior to randomization.
Current smoker (or has quit smoking for less than 1 year)
Current active malignancy

Where it is running

Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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