Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser

• Register: ClinicalTrials.gov
• Last refreshed on: 6 February 2023
• Main ID: NCT02431104
• Date of registration: 27/04/2015
• Prospective Registration: No
• Primary sponsor: Cutera Inc.
• Public title: Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser
• Scientific title: Clinical Evaluation of Tattoo Removal Using a Novel Dual-Wavelength, Dual-Pulse Duration Laser"
• Date of first enrolment: April 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02431104
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Sheetal Sapra, MD
• Affiliation: ICLS Dermatology and Plastic Surgery

Key inclusion & exclusion criteria

Inclusion Criteria:

- Fitzpatrick Skin Type I - VI

- Target tattoo contains only black ink, is more than 1 year old and must have been
obtained from a professional tattoo parlor.

- Wiling to cover tattoos with a bandage or clothing; and/or have very limited sun
exposure and use an approved sunscreen of SPF 50 or higher on the treated area
starting 2 to 4 weeks before the treatment and/or every day for the duration of the
study, including the follow-up period.

Exclusion Criteria:

- Target tattoo is 'home made' OR was obtained from an amateur artist.

- Presence of double tattoo in the treatment area or presence of tribal, scarred,
high-ink density, or highly colorful single tattoo.

- Participation in a clinical trial of another device or drug within 6 months prior to
enrollment or during the study.

- History of allergic reaction to pigments following tattooing.

- History of allergy to local anesthetics.

- History of malignant tumors in the target area.

- History of keloid scarring, hypertrophic scarring or of abnormal wound healing.

- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning
during the study.

- Current smoker or history of smoking within 6 months of study participation.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Laser Tattoo Removal

Intervention(s)

Device: 532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser

Primary Outcome(s)

Physician's Global Assessment of improvement post-final treatment [Time Frame: 3 months]

Secondary Outcome(s)

Subject Satisfaction post-final treatment [Time Frame: 3 months]

Incidence and severity of adverse device effects [Time Frame: Day 0, 4 wks, 8wks, 12 wks, 16 wks, 28 wks]

Subject's Global Assessment of improvement post-final treatment [Time Frame: 3 months]

Secondary ID(s)

C-15-EN02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors