Trial Outcomes & Findings for Evaluation of the 755nm Alexandrite Laser for the Treatment of Tattoos (NCT NCT01754207)
NCT ID: NCT01754207
Last Updated: 2020-12-16
Results Overview
2D photography comparing pre and post treatment photos, where the percentage of tattoo clearance between the photos was determined by the evaluator.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
up to 3 months post last treatment
Results posted on
2020-12-16
Participant Flow
Participant milestones
| Measure |
755nm Alexandrite Laser
755nm Alexandrite Laser
755nm Alexandrite Laser: 755nm Alexandrite Laser
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the 755nm Alexandrite Laser for the Treatment of Tattoos
Baseline characteristics by cohort
| Measure |
755nm Alexandrite Laser
n=20 Participants
755nm Alexandrite Laser
755nm Alexandrite Laser: 755nm Alexandrite Laser
755nm Alexandrite Laser with CAP Array: 755nm Alexandrite Laser with CAP Array
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Score I
|
4 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Score II
|
9 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Score III
|
6 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Score IV
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Score V
|
0 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Fitzpatrick Skin Score VI
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 3 months post last treatment2D photography comparing pre and post treatment photos, where the percentage of tattoo clearance between the photos was determined by the evaluator.
Outcome measures
| Measure |
755nm Alexandrite Laser
n=23 Tattoos
755nm Alexandrite Laser
755nm Alexandrite Laser: 755nm Alexandrite Laser
755nm Alexandrite Laser with CAP Array: 755nm Alexandrite Laser with CAP Array
|
|---|---|
|
Tattoo Clearance Using Photographic Evaluation
>75% clearance
|
15 Tattoos
|
|
Tattoo Clearance Using Photographic Evaluation
51-74% clearance
|
6 Tattoos
|
|
Tattoo Clearance Using Photographic Evaluation
<25% clearance
|
2 Tattoos
|
Adverse Events
755nm Alexandrite Laser
Serious events: 0 serious events
Other events: 20 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
755nm Alexandrite Laser: 755nm Alexandrite Laser
755nm Alexandrite Laser with CAP Array: 755nm Alexandrite Laser with CAP Array
|
|---|---|
|
Nervous system disorders
Pain
|
45.0%
9/20 • 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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
80.0%
16/20 • 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.
|
|
Skin and subcutaneous tissue disorders
Pinpoint Bleeding
|
50.0%
10/20 • 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.
|
|
Skin and subcutaneous tissue disorders
Edema
|
80.0%
16/20 • 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.
|
|
Skin and subcutaneous tissue disorders
Crusting
|
75.0%
15/20 • 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.
|
|
Skin and subcutaneous tissue disorders
Scabbing
|
70.0%
14/20 • 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.
|
|
Skin and subcutaneous tissue disorders
Blistering
|
80.0%
16/20 • 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.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
30.0%
6/20 • 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.
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
10.0%
2/20 • 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.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
15.0%
3/20 • 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.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
5.0%
1/20 • 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.
|
|
Skin and subcutaneous tissue disorders
Other
|
10.0%
2/20 • 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.
|
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