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The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles using the picosecond 755nm Alexandrite laser.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 755nm Alexandrite laser | Experimental | 755nm Alexandrite laser for the treatment of wrinkles |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 755nm Alexandrite laser | Device | 755nm Alexandrite laser for the treatment of wrinkles |
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| Measure | Description | Time Frame |
|---|---|---|
| Photographic Evaluation of Wrinkle Severity at Baseline | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). | Baseline |
| Photographic Evaluation of Wrinkle Severity at 1 Month Follow Up | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). | 1 Month Follow Up Post Last Treatment |
| Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). | 3 Month Follow Up Post Last Treatment |
| Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). | 4 months post last treatment |
| Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). | 6 months post last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maryland Laser, Skin and Vein Institute | Hunt Valley | Maryland | 21030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 755nm Alexandrite Laser | 755nm Alexandrite laser for the treatment of wrinkles 755nm Alexandrite laser: 755nm Alexandrite laser for the treatment of wrinkles |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 755nm Alexandrite Laser | 755nm Alexandrite laser for the treatment of wrinkles 755nm Alexandrite laser: 755nm Alexandrite laser for the treatment of wrinkles |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Photographic Evaluation of Wrinkle Severity at Baseline | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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Adverse event data were collected from study start until 6 month post last treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 755nm Alexandrite Laser | 755nm Alexandrite laser for the treatment of wrinkles 755nm Alexandrite laser: 755nm Alexandrite laser for the treatment of wrinkles |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Trimper | Cynosure | 800-886-2966 | jamie.trimper@cynosure.com |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Fitzpatrick Skin Type | Measure Description: The Fitzpatrick Skin Score is used to determine skin color. It is a numerical system that classifies skin into six types (Type I, Type II, Type III, Type IV, Type V and Type VI) based on the numerical score achieved (ranging from 0 to 36). The lower the score (and skin type number), the fairer the skin. The higher the score (and skin type number), the more deeply pigmented the skin is. The scale comes from this source: Gupta, Sharma. Skin typing: Fitzpatrick grading and others. Clinics in Dermatology. 2019;37(5):430-436. doi:10.1016/j.clindermatol.2019.07.010 | Count of Participants | Participants |
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| Primary | Photographic Evaluation of Wrinkle Severity at 1 Month Follow Up | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). | One subject did not show up to their follow up appointment. | Posted | Mean | Standard Deviation | score on a scale | 1 Month Follow Up Post Last Treatment |
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| Primary | Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). | Posted | Mean | Standard Deviation | score on a scale | 3 Month Follow Up Post Last Treatment |
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| Primary | Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). | 2 subjects did not show up for their follow ups. | Posted | Mean | Standard Deviation | score on a scale | 4 months post last treatment |
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| Primary | Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up | Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). | 2 subjects did not show up for their follow ups. | Posted | Mean | Standard Error | score on a scale | 6 months post last treatment |
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| 20 |
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| 20 |
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| 20 |
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.