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Clinical Evaluation of 755nm Alexandrite Laser Versus Nanosecond 755nm Alexandrite

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Cynosure

Status

Withdrawn

Conditions

Tattoos

Treatments

Device: 755nm Alexandrite Laser

Study type

Interventional

Funder types

Industry

Identifiers

NCT01811017
CYN12-PICO_MGH_TB

Details and patient eligibility

About

Compare the efficacy of the 755nm Alexandrite laser to the nanosecond 755nm Alexandrite laser for the removal of unwanted tattoos using photographic evaluation and histological findings.

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
  3. Is willing to consent to participate in the study.
  4. Is willing to shield the tattoo completely from sun exposure
  5. Signs informed consent form
  6. 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. Subjects who are unwilling to consent to tattoos
  2. Subjects mentally ill or incompetent
  3. Subjects is unwilling to have photographs taken and used in publications or scientific presentations
  4. Subjects who are prisoners
  5. Subjects with recent sun exposure and suntan in the area to be treated
  6. Allergic tattoos (hypersensitivity to tattoo ink)
  7. History of vitiligo or keloidal scarring
  8. Tattoos located on the neck or face including cosmetic tattoos
  9. Subjects unwilling to tolerate partial removal of the tattoo in this study
  10. Infection or skin disease in the area to be treated
  11. Subjects who are immunosuppressed (e.g. HIV)
  12. Subject is pregnant or nursing
  13. Use of oral isotretinoin within past 12 months
  14. History of squamous cell carcinoma or melanoma
  15. Is allergic to Lidocaine, tetracaine or Xylocaine with epinephrine.
  16. Has any other reason determined by the physician to be ineligible to participate in the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 2 patient groups

755nm Alexandrite Laser
Experimental group
Description:
755nm Alexandrite Laser
Treatment:
Device: 755nm Alexandrite Laser
Nanosecond 755nm Alexandrite Laser
Experimental group
Description:
Nanosecond 755nm Alexandrite Laser
Treatment:
Device: 755nm Alexandrite Laser

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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