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CompletedNCT01842815Updated Jan 5, 2021Results posted

Evaluation of the 755nm Alexandrite for Unwanted Tattoos

An interventional study of 755 nm alexandrite laser in Unwanted, Non Cosmetic, Tattoos, sponsored by Cynosure, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-01-05.

Sponsored by Cynosure, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The purpose of this study is to collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using a 755nm Alexandrite laser.

02

Conditions studied

  • Unwanted, Non Cosmetic, Tattoos
03

In context

Lead sponsor

Cynosure, Inc. is the lead sponsor of 52 studies on the registry; 2 are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 16 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Is a healthy male or female between 18 and 85 years old.
  2. Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments to remove them.
  3. Is willing to consent to participate in the study.
  4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.

Exclusion criteria

Exclusion Criteria:

  1. Is hypersensitive to light exposure.
  2. Has active localized or systemic infection.
  3. Is taking medication(s) for which sunlight is a contraindication.
  4. Has a history of squamous cell carcinoma or melanoma.
  5. Has a history of keloid scarring.
  6. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
  7. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
  8. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
  9. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
  10. Has any other reason determined by the physician to be ineligible to participate in the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    755nm Alexandrite Laser Single Pass (Right Side).

    755nm Alexandrite Laser for Treatment of unwanted, non cosmetic tattoos. The right side will be treated once within the same visit.

    Device: 755 nm alexandrite laser

  • Experimental
    755nm Alexandrite Laser Double Pass (Left Side)

    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.

    Device: 755 nm alexandrite laser

Interventions

  • Device755 nm alexandrite laser

    755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.

06

What researchers measure

Primary outcomes

  1. Tattoo Clearance

    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.

    Time frame: Post Treatment 1 (6 Weeks Post Baseline)

  2. Tattoo Clearance

    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.

    Time frame: Post Treatment 2 (12 Weeks Post Baseline)

  3. Tattoo Clearance

    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.

    Time frame: Post Treatment 3 (18 Weeks Post Baseline)

07

Results

Posted Jan 5, 2021

Participant flow

Participant flow — Overall Study
Milestone755nm Alexandrite Laser
Started20
Completed16
Not completed4

Outcome measures

PrimaryTattoo Clearance

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.

Time frame:
Post Treatment 1 (6 Weeks Post Baseline)
Reported as:
Mean · score on a scale
Tattoo Clearance
score on a scale755nm Alexandrite Laser Single Pass (Right Side).755nm Alexandrite Laser Double Pass (Left Side)
Tattoo Clearance2.875 ± 2.1124.25 ± 2.513
Statistical analysis
  • 755nm Alexandrite Laser Single Pass (Right Side). vs 755nm Alexandrite Laser Double Pass (Left Side) · t-test, 2 sided · p = .0077 (The value looked at for statistical significance is if p\<.05.)t-tailed, paired t-test
PrimaryTattoo Clearance

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.

Time frame:
Post Treatment 2 (12 Weeks Post Baseline)
Reported as:
Mean · score on a scale
Tattoo Clearance
score on a scale755nm Alexandrite Laser Single Pass (Right Side).755nm Alexandrite Laser Double Pass (Left Side)
Tattoo Clearance3.75 ± 2.214.88 ± 2.58
Statistical analysis
  • 755nm Alexandrite Laser Single Pass (Right Side). vs 755nm Alexandrite Laser Double Pass (Left Side) · t-test, 2 sided · p = .00012 (The value looked at for statistical significance is if p\<.05.)t-tailed, paired t-test
PrimaryTattoo Clearance

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.

Time frame:
Post Treatment 3 (18 Weeks Post Baseline)
Reported as:
Mean · score on a scale
Tattoo Clearance
score on a scale755nm Alexandrite Laser Single Pass (Right Side).755nm Alexandrite Laser Double Pass (Left Side)
Tattoo Clearance4.5 ± 2.485.77 ± 2.83
Statistical analysis
  • 755nm Alexandrite Laser Single Pass (Right Side). vs 755nm Alexandrite Laser Double Pass (Left Side) · t-test, 2 sided · p = .0034 (The value looked at for statistical significance is if p\<.05.)t-tailed, paired t-test

Adverse events

Collected over Adverse data were collected from the first treatment until 3 months post-treatment.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
755nm Alexandrite Laser0/20 (0%)0/20 (0%)4/20 (20%)
Most frequent other events
Most frequent other events
Event755nm Alexandrite Laser
HypopigmentationSkin and subcutaneous tissue disorders3/20
HyperpigmentationSkin and subcutaneous tissue disorders2/20
BlisteringSkin and subcutaneous tissue disorders1/20

Baseline characteristics

1 subject withdrew, per sponsor request, due to multiple laser devices already used on treatment area. They withdrew before baseline information was taken of them.

Age, Categorical
Age, Categorical(Participants)755nm Alexandrite Laser
<=18 years0
Between 18 and 65 years19
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)755nm Alexandrite Laser
Female5
Male14
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)755nm Alexandrite Laser
Race/Ethnicity — Caucasian12
Race/Ethnicity — Asian0
Race/Ethnicity — African American1
Race/Ethnicity — Hispanic4
Race/Ethnicity — Native American1
Race/Ethnicity — Other1
Fitzpatrick Skin Type
Fitzpatrick Skin Type(Participants)755nm Alexandrite Laser
Fitzpatrick Skin Type I1
Fitzpatrick Skin Type II6
Fitzpatrick Skin Type III7
Fitzpatrick Skin Type IV4
Fitzpatrick Skin Type V1
Fitzpatrick Skin Type VI0
08

Study locations

1 site
  • Laser & Skin Surgery Center of Northern California
    Sacramento, California 95816, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01842815
Lead sponsor
Cynosure, Inc.
Responsible party
Sponsor
First posted
Apr 30, 2013
Start date
Mar 2013
Primary completion
Dec 2015
Completion
Dec 2015
Results posted
Jan 5, 2021
Last update
Jan 5, 2021

Study contacts

Patricia Krantz
study director · Cynosure, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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