N/A N=20 Treatment

Evaluation of the 755nm Alexandrite for Unwanted Tattoos

Unwanted, Non Cosmetic, Tattoos

Bottom Line

View on ClinicalTrials.gov: NCT01842815 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcome: Primary: Tattoo Clearance — 2.875; 4.25 score on a scale — p=.0077

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 755 nm alexandrite laser (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cynosure, Inc.
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Tattoo Clearance	4.5; 5.77	.0034 sig
PRIMARY Tattoo Clearance	4.5; 5.77	.0034 sig
PRIMARY Tattoo Clearance	4.5; 5.77	.0034 sig

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.

Eligibility Criteria

Inclusion Criteria

Is a healthy male or female between 18 and 85 years old.
Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments to remove them.
Is willing to consent to participate in the study.
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

Is hypersensitive to light exposure.
Has active localized or systemic infection.
Is taking medication(s) for which sunlight is a contraindication.
Has a history of squamous cell carcinoma or melanoma.
Has a history of keloid scarring.
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.
Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
Has any other reason determined by the physician to be ineligible to participate in the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01842815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.