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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane | Experimental | half the chest to be treated with Restylane Silk |
|
| Placebo | Placebo Comparator | half-chest injections with saline as a placebo to Restylane Silk. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Silk | Drug | Restylane Silk is a temporary hyaluronic acid filler currently approved for the lips and fine lines around the mouth. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Waldorf, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Giselle Singer | Icahn School of Medicine at Mount Sinai | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Drug | Saline as placebo |
|
| Optical Coherence Tomography | Device | An FDA-cleared non-invasive imaging device |
|
|
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 |
| D017670 |
| Sodium Compounds |
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |