Restylane Silk for Treatment of Chest Wrinkles

Study Overview
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Brief Summary
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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
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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.

Official Title
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Small Particle Hyaluronic Acid-Based Gel (Restylane Silk) for Treatment of Chest Wrinkles: A Randomized, Double-Blinded, Placebo-Controlled, Clinical Trial of Efficacy and Safety

Conditions
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Wrinkle

Intervention / Treatment
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* Drug: Restylane Silk
* Drug: Saline
* Device: Optical Coherence Tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restylane<br>half the chest to be treated with Restylane Silk | Drug: Restylane Silk<br>* Restylane Silk is a temporary hyaluronic acid filler currently approved for the lips and fine lines around the mouth.<br>Device: Optical Coherence Tomography<br>* An FDA-cleared non-invasive imaging device<br>* Other names: OCT;|
| Placebo Comparator: Placebo<br>half-chest injections with saline as a placebo to Restylane Silk. | Drug: Saline<br>* Saline as placebo<br>Device: Optical Coherence Tomography<br>* An FDA-cleared non-invasive imaging device<br>* Other names: OCT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fabi-Bolton (FB) clinometric chest wrinkle scale | The change from baseline in blinded evaluator assessments of chest/décolletage and 6 months assessed by the Fabi-Bolton (FB) chest wrinkle. The Fabi-Bolton (F-B) 5-point wrinkle scale (1 = wrinkles absent; 2 = shallow but visible wrinkles; 3 = moderately deep wrinkles; 4 = deep wrinkles, with well-defined edges; 5 = wrinkles very deep with redundant folds). | Baseline and 6 months | 
| Incidence of reported treatment emergent adverse events | The incidence of reported treatment emergent adverse events | up to 360 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dermal thickness | Achieving statistically significant changes in optical coherence tomography (OCT) (epidermal, papillary, and visible reticular dermal thickness) at 6 months after 3 treatment sessions given | Baseline and 6 months | 
| Change in papillary dermal brightness | Achieving statistically significant changes in OCT parameters (papillary dermal brightness) at day 180 after 3 treatment sessions given | Baseline and 6 months | 
| Change in upper dermal reflectivity | Achieving statistically significant changes in OCT parameters (upper dermal reflectivity) at day 180 after 3 treatment sessions given | Baseline and 6 months | 
| Change in dermoepidermal contrast | Achieving statistically significant changes in OCT parameters (dermoepidermal contrast) at day 180 after 3 treatment sessions given | Baseline and 6 months | 
| Change in surface contouring | Achieving statistically significant changes in OCT parameters (surface contouring) at day 180 after 3 treatment sessions given | Baseline and 6 months | 
| Patient satisfaction | The questionnaire consists of two Yes/No questions (score 0 or 1) and five questions using a 5 point Likert rating scale with scores ranging from 0 (extremely dissatisfied) to 5 (extremely satisfied). The total score range is from 0-27. | 6 months |