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CompletedNCT01754207Updated Dec 16, 2020Results posted

Evaluation of the 755nm Alexandrite Laser for the Treatment of Tattoos

An interventional study of 755nm Alexandrite Laser and 755nm Alexandrite Laser with CAP Array in 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 2020-12-16.

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

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
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 the 755nm Alexandrite laser.

02

Conditions studied

  • 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    755nm Alexandrite Laser

    755nm Alexandrite Laser

    Device: 755nm Alexandrite Laser · Device: 755nm Alexandrite Laser with CAP Array

Interventions

  • Device755nm Alexandrite Laser

    755nm Alexandrite Laser

  • Device755nm Alexandrite Laser with CAP Array

    755nm Alexandrite Laser with CAP Array

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 3 months post last treatment

07

Results

Posted Dec 16, 2020

Participant flow

Participant flow — Overall Study
Milestone755nm Alexandrite Laser
Started20
Completed17
Not completed3

Outcome measures

PrimaryTattoo 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.

Time frame:
up to 3 months post last treatment
Reported as:
Count of units · Tattoos
Tattoo Clearance Using Photographic Evaluation
Tattoos755nm Alexandrite Laser
>75% clearance15
51-74% clearance6
<25% clearance2

Adverse events

Collected over Adverse Events occurring were captured for the study duration, around 12 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
755nm Alexandrite Laser0/20 (0%)0/20 (0%)20/20 (100%)
Most frequent other events
Showing 10 of 12
Most frequent other events
Event755nm Alexandrite Laser
ErythemaSkin and subcutaneous tissue disorders16/20
EdemaSkin and subcutaneous tissue disorders16/20
BlisteringSkin and subcutaneous tissue disorders16/20
CrustingSkin and subcutaneous tissue disorders15/20
ScabbingSkin and subcutaneous tissue disorders14/20
Pinpoint BleedingSkin and subcutaneous tissue disorders10/20
PainNervous system disorders9/20
PurpuraSkin and subcutaneous tissue disorders6/20
HyperpigmentationSkin and subcutaneous tissue disorders3/20
HypopigmentationSkin and subcutaneous tissue disorders2/20

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)755nm Alexandrite Laser
<=18 years0
Between 18 and 65 years20
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)755nm Alexandrite Laser
Female15
Male5
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)755nm Alexandrite Laser
Race/Ethnicity — Caucasian18
Race/Ethnicity — Hispanic1
Race/Ethnicity — African American1
Fitzpatrick Skin Type
Fitzpatrick Skin Type(Participants)755nm Alexandrite Laser
Fitzpatrick Skin Score I4
Fitzpatrick Skin Score II9
Fitzpatrick Skin Score III6
Fitzpatrick Skin Score IV1
Fitzpatrick Skin Score V0
Fitzpatrick Skin Score VI0
08

Study locations

1 site
  • Skin Care Physicians
    Chestnut Hill, Massachusetts 02467, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01754207
Lead sponsor
Cynosure, Inc.
Responsible party
Sponsor
First posted
Dec 21, 2012
Start date
Dec 2011
Primary completion
Jan 2014
Completion
Jan 2014
Results posted
Dec 16, 2020
Last update
Dec 16, 2020

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 Nov 2020. You cannot join it, but the record below documents what was studied.

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