Restylane Silk for Treatment of Chest Wrinkles

NCT ID: NCT03324997

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-28
• Study Completion Date: 2018-01-28

Brief Summary

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.

Detailed Description

Restylane Silk has been safely and effectively used in rejuvenation and appearance of wrinkles in the face. This study seeks to investigate the safety and efficacy of the injectable device in the chest for similar effects. Participants will undergo three treatments with Restylane Silk and results will be measured clinically and with Optical Coherence Tomography (an FDA-cleared non-invasive imaging device). Participants will receive randomized injections with the Restylane Silk product on half of the chest and will receive placebo injections on the other half. At the six-month period, participants will have the option to receive treatment with the product on the placebo side. At the 12-month period, participants may also elect for three additional touch-up treatments, which will not be counted as part of the study. If the chest is asymmetric in regards to wrinkles, the investigators will still proceed with the protocol because they are also comparing each side to itself prior to treatment, instead of simply comparing one side to the other.

Conditions

Wrinkle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Restylane

half the chest to be treated with Restylane Silk

Group Type: EXPERIMENTAL

Restylane Silk

Intervention Type: DRUG

Restylane Silk is a temporary hyaluronic acid filler currently approved for the lips and fine lines around the mouth.

Optical Coherence Tomography

Intervention Type: DEVICE

An FDA-cleared non-invasive imaging device

Placebo

half-chest injections with saline as a placebo to Restylane Silk.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Saline as placebo

Optical Coherence Tomography

Intervention Type: DEVICE

An FDA-cleared non-invasive imaging device

Interventions

Restylane Silk

Restylane Silk is a temporary hyaluronic acid filler currently approved for the lips and fine lines around the mouth.

Intervention Type: DRUG

Saline

Saline as placebo

Intervention Type: DRUG

Optical Coherence Tomography

An FDA-cleared non-invasive imaging device

Intervention Type: DEVICE

Other Intervention Names

OCT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Heidi Waldorf

OTHER

Sponsor Role: lead

Responsible Party

Heidi Waldorf

Associate Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Heidi Waldorf, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Giselle Singer

Role: STUDY_DIRECTOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

GCO 16-2676

Identifier Type: -

Identifier Source: org_study_id