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 evaluate the safety and efficacy of laser tattoo removal with picosecond pulse durations as compared to treatment with nanosecond pulse durations using a single novel Q-Switched (QS) Nd:YAG laser.
This is a randomized, split-tattoo, open-label, single-center study of up to 25 subjects with tattoos containing black or dark blue ink, alone or in combination with other colors. It will compare the safety and efficacy of nanosecond and picosecond pulse durations with the Cutera Picosecond Q-Switched Nd:YAG laser for tattoo removal.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enLighten Laser Picosecond Pulse | Experimental | Picosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment |
|
| enLighten Laser Nanosecond Pulse | Experimental | Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enLighten Laser | Device | Picosecond pulse-duration or Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of Tattoo Clearing at 12 Weeks for Each Treatment Arm as Assessed by the Blinded Reviewers. | Physician's Global Assessment (min=0; Max=4) Higher scores indicate better outcomes | 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| E. Victor Ross, MD | Scripps Clinic Carmel Valley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic Carmel Valley | San Diego | California | 92130 | United States |
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Subject tattoos were divided into 2 sides for assignment into 2 arms for treatment by the Picosecond and Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) : active control arm and treatment arm. One side will receive treatment with the picosecond pulse duration and one side will receive treatment with the nanosecond pulse duration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Subjects All Enrolled Subjects | Picosecond and Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment |
| 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 | Level of Tattoo Clearing at 12 Weeks for Each Treatment Arm as Assessed by the Blinded Reviewers. | Physician's Global Assessment (min=0; Max=4) Higher scores indicate better outcomes | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
12 weeks
Not provided
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 | enLighten Laser Picosecond Pulse | Picosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment enLighten Laser: Picosecond pulse-duration or Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margot Doucette | Cutera | 415-657-5518 | mdoucette@cutera.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 10 |
| 10 |
| EG001 | enLighten Laser Nanosecond Pulse | Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment enLighten Laser: Picosecond pulse-duration or Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment | 0 | 10 | 0 | 10 | 10 | 10 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided