ClinicalTrials.Veeva

Menu

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

Cynosure logo

Cynosure

Status

Completed

Conditions

Tattoos

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01754207
CYN11-PICO-D-A-TAT

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

  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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

755nm Alexandrite Laser
Experimental group
Description:
755nm Alexandrite Laser
Treatment:
Device: 755nm Alexandrite Laser with CAP Array
Device: 755nm Alexandrite Laser

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems