Trial Outcomes & Findings for Evaluation of the 755nm Alexandrite for Unwanted Tattoos (NCT NCT01842815)
NCT ID: NCT01842815
Last Updated: 2021-01-05
Results Overview
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Post Treatment 1 (6 Weeks Post Baseline)
Results posted on
2021-01-05
Participant Flow
All subjects are enrolled in both study arms because all subjects will be receiving treatment on the left side of the tattoo and treatment on the right side of the tattoo in each visit.
Unit of analysis: treatment areas
Participant milestones
| Measure |
755nm Alexandrite Laser
755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos
755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.
|
|---|---|
|
Overall Study
STARTED
|
20 26
|
|
Overall Study
COMPLETED
|
16 22
|
|
Overall Study
NOT COMPLETED
|
4 4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the 755nm Alexandrite for Unwanted Tattoos
Baseline characteristics by cohort
| Measure |
755nm Alexandrite Laser
n=19 Participants
755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos
755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Native American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Type I
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Type II
|
6 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Type III
|
7 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Type IV
|
4 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Type V
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Type VI
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post Treatment 1 (6 Weeks Post Baseline)Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo.
Outcome measures
| Measure |
755nm Alexandrite Laser Single Pass (Right Side).
n=24 tattoos
755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The right side will be treated once within the same visit.
755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.
|
755nm Alexandrite Laser Double Pass (Left Side)
n=24 tattoos
755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The left side of the tattoo will be treated twice within the same visit 20 minutes apart.
755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.
|
|---|---|---|
|
Tattoo Clearance
|
2.875 score on a scale
Standard Deviation 2.112
|
4.25 score on a scale
Standard Deviation 2.513
|
PRIMARY outcome
Timeframe: Post Treatment 2 (12 Weeks Post Baseline)Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo.
Outcome measures
| Measure |
755nm Alexandrite Laser Single Pass (Right Side).
n=24 tattoos
755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The right side will be treated once within the same visit.
755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.
|
755nm Alexandrite Laser Double Pass (Left Side)
n=24 tattoos
755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The left side of the tattoo will be treated twice within the same visit 20 minutes apart.
755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.
|
|---|---|---|
|
Tattoo Clearance
|
3.75 score on a scale
Standard Deviation 2.21
|
4.88 score on a scale
Standard Deviation 2.58
|
PRIMARY outcome
Timeframe: Post Treatment 3 (18 Weeks Post Baseline)Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo.
Outcome measures
| Measure |
755nm Alexandrite Laser Single Pass (Right Side).
n=24 tattoos
755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The right side will be treated once within the same visit.
755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.
|
755nm Alexandrite Laser Double Pass (Left Side)
n=24 tattoos
755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The left side of the tattoo will be treated twice within the same visit 20 minutes apart.
755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.
|
|---|---|---|
|
Tattoo Clearance
|
4.5 score on a scale
Standard Deviation 2.48
|
5.77 score on a scale
Standard Deviation 2.83
|
Adverse Events
755nm Alexandrite Laser
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
755nm Alexandrite Laser
n=20 participants at risk
755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos
755 nm alexandrite laser: 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
15.0%
3/20 • Adverse data were collected from the first treatment until 3 months post-treatment.
The adverse events were reported in 1 group instead of 2 (right vs. left) because that distinction in adverse events collection was not examined or required for this study's aims.
|
|
Skin and subcutaneous tissue disorders
Blistering
|
5.0%
1/20 • Adverse data were collected from the first treatment until 3 months post-treatment.
The adverse events were reported in 1 group instead of 2 (right vs. left) because that distinction in adverse events collection was not examined or required for this study's aims.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
10.0%
2/20 • Adverse data were collected from the first treatment until 3 months post-treatment.
The adverse events were reported in 1 group instead of 2 (right vs. left) because that distinction in adverse events collection was not examined or required for this study's aims.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
- Publication restrictions are in place
Restriction type: OTHER