Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using the 755nm Alexandrite laser.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tattoo Clearance Using Photographic Evaluation | 2D photography comparing pre and post treatment photos, where the percentage of tattoo clearance between the photos was determined by the evaluator. | up to 3 months post last treatment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patricia Krantz | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Care Physicians | Chestnut Hill | Massachusetts | 02467 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 755nm Alexandrite Laser | 755nm Alexandrite Laser 755nm Alexandrite Laser: 755nm Alexandrite Laser |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 755nm Alexandrite Laser | 755nm Alexandrite Laser 755nm Alexandrite Laser: 755nm Alexandrite Laser 755nm Alexandrite Laser with CAP Array: 755nm Alexandrite Laser with CAP Array |
| 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 | Tattoo Clearance Using Photographic Evaluation | 2D photography comparing pre and post treatment photos, where the percentage of tattoo clearance between the photos was determined by the evaluator. | Posted | Count of Units | Tattoos | up to 3 months post last treatment | Tattoos | Tattoos |
|
|
Adverse Events occurring were captured for the study duration, around 12 months.
Adverse Events listed under "other" were monitored/assessed without regard to the specific Adverse Event Term.
Not provided
| 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 755nm Alexandrite Laser with CAP Array: 755nm Alexandrite Laser with CAP Array |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Trimper | Cynosure | 800-886-2966 | jamie.trimper@cynosure.com |
Not provided
| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 755nm Alexandrite Laser with CAP Array |
| Device |
755nm Alexandrite Laser with CAP Array |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Fitzpatrick Skin Type | 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 |
|
| Tattoos |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 20 |
| 20 |
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pinpoint Bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Crusting | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Scabbing | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Blistering | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypopigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Other | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.