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

Tattoos Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01811017
• Other study ID #: CYN12-PICO_MGH_TB
• Status: Withdrawn
• Phase: N/A
• First received: December 6, 2012
• Last updated: February 3, 2014
• Start date: June 2012
• Est. completion date: May 2013

Study information

• Verified date: February 2014
• Source: Cynosure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tattoos

Intervention

Device:
• 755nm Alexandrite Laser
755nm Alexandrite Laser

Locations

Country	Name	City	State
United States	Boston Va Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cynosure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events as a measure of safety and tolerability		up to 3 months post last treatment	Yes
Primary	Photographic Evaluation of Tattoo Clearance		up to 3 months post last treatment	No
Secondary	Subject biopsy sampling	Histological evaluation of tissue samples pre-treatment and post-treatment	up to 3 months post last treatment	Yes