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The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles using a 755nm Alexandrite Laser.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 755nm Alexandrite Laser | Experimental | 755nm Alexandrite Laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 755nm Alexandrite Laser | Device | 755nm Alexandrite Laser for the treatment of Wrinkles |
|
| 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). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis. | Baseline |
| Photographic Evaluation of Wrinkle Severity at 1 Month Post Last Treatment | 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). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis. | 1 Month Follow Up Post Last Treatment |
| Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up Post Last Treatment | 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). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis. | 3 Month Follow Up Post Last Treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction Questionnaire | up to 6 months post last treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McDaniel Institute of Anti Aging Research | Virginia Beach | Virginia | 23462 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 755nm Alexandrite Laser | 755nm Alexandrite Laser 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 755nm Alexandrite Laser: 755nm Alexandrite Laser for the treatment of Wrinkles |
| Units | Counts |
|---|---|
| Participants |
|
| 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). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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The adverse event data were collected up to 6 months 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 755nm Alexandrite Laser: 755nm Alexandrite Laser for the treatment of Wrinkles |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain | Nervous system disorders | Systematic Assessment |
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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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| Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up Post Last Treatment | 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). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis. | 4 Month Follow Up Post Last Treatment |
| Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up Post Last Treatment | 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). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis. | 6 Month Follow Up Post Last Treatment |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Fitzpatrick Skin Type Score | 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 Post Last Treatment | 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). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis. | One subject was unable to return to clinic for the 1 month visit due to a family emergency. | 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 Post Last Treatment | 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). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis. | 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 Post Last Treatment | 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). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis. | Posted | Mean | Standard Deviation | score on a scale | 4 Month Follow Up Post Last Treatment |
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| Primary | Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up Post Last Treatment | 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). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis. | Posted | Mean | Standard Deviation | score on a scale | 6 Month Follow Up Post Last Treatment |
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| Other Pre-specified | Satisfaction Questionnaire | Not Posted | up to 6 months post last treatment | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| 19 |
| 20 |
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dryness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.