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Evaluate the Safety and Efficacy of the Mosaic Ultra 1550nm system for the treatment of skin tone and texture, facial rejuvenation, photoaging, wrinkles, scars, stretch marks, acne vulgaris and hair loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Subjects will be treated up to 5 times with a 30- and 90-day post final-treatment follow-up. Subjects may be asked to participate in an elective biopsy collected from normal skin simultaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mosaic | Device | 1550 Fractional Laser System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Photographic Assessment | Evaluation of Randomized Before Treatment and 3-Month Follow-Up Images by Blinded Evaluators | 90-day Follow-Up |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment | Evaluation of Adverse Events | up to 90 days post final treatment |
| Subject Satisfaction | Scoring of Satisfaction from Extremely Satisfied to Extremely Dissatisfied |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Denis | Contact | 9788959206 | adenis@lutronic.com | |
| Paul Cardiarelli | Contact | 8012440058 | pcardarelli@lutronic.com |
| Name | Affiliation | Role |
|---|---|---|
| Omar Ibrahimi | Lutronic Medical Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Dermatology | Recruiting | Lincolnshire | Illinois | 60069 | United States |
Plan will not be shared
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2023 | Oct 23, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D057896 | Striae Distensae |
| D000152 | Acne Vulgaris |
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
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| 30-day and 90-day Follow-Up |
| Physician Satisfaction | Scoring of Satisfaction from Extremely Satisfied to Extremely Dissatisfied | 30-day and 90-day Follow-Up |
| Subject Clinical Global Aesthetic Improvement Scale | Scoring on the Clinical Global Aesthetic Improvement Scale is completed by having the subject select one option from the scale corresponding to their perspective of the improvement seen in their treated conditions. Response options are 1 - Very Much Improved, 2 - Much Improved, 3 - Improved, 4 - No Change, and 5 - Worsened. A response of 1 - Very Much Improved is the best outcome while a score of 5 - Worsened is the worse outcome. | 30-day and 90-day Follow-Up |
| Physician Clinical Global Aesthetic Improvement Scale | Scoring on the Clinical Global Aesthetic Improvement Scale is completed by having the physician select one option from the scale corresponding to their perspective of the improvement seen in their treated conditions of the subject. Response options are 1 - Very Much Improved, 2 - Much Improved, 3 - Improved, 4 - No Change, and 5 - Worsened. A response of 1 - Very Much Improved is the best outcome while a score of 5 - Worsened is the worse outcome. | 30-day and 90-day Follow-Up |
| Coagulation Zone Measurements | Biopsies taken from healthy tissue prior to treatment up to 21 days post treatment to evaluate histological effect of the device. Tissue samples will be evaluated and the depth and width of the coagulation zones due to the laser (measures in micrometers) | Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post |
| Epidermal Inflammatory Response | Biopsies taken from healthy tissue prior to treatment up to 21 days post treatment to evaluate histological effect of the device. Tissue samples will be reviewed for markers of inflammation and coagulation in the epidermis. General comments and observations of the tissue will be completed by a pathologist. | Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post |
| Dermal Inflammatory Response | Biopsies taken from healthy tissue prior to treatment up to 21 days post treatment to evaluate histological effect of the device. Tissue samples will be reviewed for markers of inflammation and coagulation in the dermis. General comments and observations of the tissue will be completed by a pathologist. | Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post |
| Tissue Reepithelization | Biopsies taken from healthy tissue prior to treatment up to 21 days post treatment to evaluate histological effect of the device. Tissue samples will be evaluated to determine the timepoint in which there is a reepithelization of the treated tissue. Timepoint of reepithelization will be determined by a pathologist reviewing the imaging. | Baseline, Immediate Post Treatment, 4 Days Post, 14 Days Post, 21 Days Post |
| Lutronic | Recruiting | Billerica | Massachusetts | 01821 | United States |
|
| Dermatology & Skin Health | Recruiting | Peabody | Massachusetts | 01960 | United States |
|
| D012816 | Signs and Symptoms |
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D020763 | Pathological Conditions, Anatomical |