CompletedNot Applicable

Pilot Study of Multi-wavelength Laser for Tattoo Removal

United States22 participantsStarted 2015-07-08

Plain-language summary

To evaluate the safety and efficacy of an investigational version of the Cutera enLighten laser that offers muliple wavelengths for tattoo removal.

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Female or Male, 18 to 65 years of age (inclusive).
✓. Fitzpatrick Skin Type I - VI (Appendix 3).
✓. Target tattoo contains single or multi-color ink.
✓. Subject must be able to read, understand and sign the Informed Consent Form.
✓. Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
✓. 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.
✓. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
✓. Agree to not undergo any other procedure(s) for tattoo removal during the study (as applicable).

✕. Participation in a clinical trial of a drug or another device in the target area during the study..
✕. Target tattoo contains only black ink.
✕. History of allergic reaction to pigments following tattooing..
✕. History of allergy to local anesthetics.
✕. History of allergy to topical antibiotics.
✕. History of malignant tumors in the target area.
✕. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
✕. Pregnant and/or breastfeeding.

Degree of Tattoo Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator

Timeframe: 6 weeks post-final treatment

NCT IDNCT03290547

SponsorCutera Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11-29

Results submitted2023-08-21

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Female or Male, 18 to 65 years of age (inclusive).
✓. Fitzpatrick Skin Type I - VI (Appendix 3).
✓. Target tattoo contains single or multi-color ink.
✓. Subject must be able to read, understand and sign the Informed Consent Form.
✓. Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
✓. 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.
✓. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
✓. Agree to not undergo any other procedure(s) for tattoo removal during the study (as applicable).

✕. Participation in a clinical trial of a drug or another device in the target area during the study..
✕. Target tattoo contains only black ink.
✕. History of allergic reaction to pigments following tattooing..
✕. History of allergy to local anesthetics.
✕. History of allergy to topical antibiotics.
✕. History of malignant tumors in the target area.
✕. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
✕. Pregnant and/or breastfeeding.