Tattoo; Pigmentation Clinical Trial
Official title:
Clinical Study to Evaluate the Performance of the PicoWayTM 1064 nm/ 785 nm/ 532nm Picosecond Laser for Tattoo Removal
Verified date | April 2017 |
Source | Syneron Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an open-label, multi-center study. Subjects in this study will receive up to eight
(8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWayTM device using the 1064
nm/ 785±20 nm/ 532 nm handpiece according to the study protocol (tattoo colors). Subjects
will return for one follow‐up (FU) visit at the clinic at 8 weeks following the last
treatment.
Methodology described in the protocol to evaluate efficacy and safety of treatments will be
carried out at each visit at the clinic
Status | Active, not recruiting |
Enrollment | 15 |
Est. completion date | December 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Healthy female and male subjects between 18 to 70 years of age 2. Fitzpatrick skin type I-VI 3. Have unwanted decorative (non-cosmetic) tattoo(s) and willing to undergo laser treatments to remove them 4. Have at least one of the following colors in the tattoo: black, green and\ or blue. 5. Willing to receive the proposed PicoWayTM treatments and comply with all study (protocol) requirements 6. Willing to have photographs and images taken of the treated areas to be used in evaluations, publications and presentations (subject identity will be masked) 7. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence) 8. Informed consent process is completed and subject consent is signed Exclusion Criteria: 1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding 2. Hypersensitivity to light exposure 3. Active sun tan 4. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course 5. Have a history of squamous cell carcinoma or melanoma 6. History of keloid scarring, abnormal wound healing and / or prone to bruising 7. Use of 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, e.g., lack of noticeable skin flaking, skin peeling and skin surface roughness. 8. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications 9. Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine 10. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study |
Country | Name | City | State |
---|---|---|---|
United States | Main Line Center for Laser Surgery | Ardmore | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Syneron Medical |
United States,
Bernstein EF, Schomacker KT, Basilavecchio LD, Plugis JM, Bhawalkar JD. A novel dual-wavelength, Nd:YAG, picosecond-domain laser safely and effectively removes multicolor tattoos. Lasers Surg Med. 2015 Jul 14. doi: 10.1002/lsm.22391. [Epub ahead of print] — View Citation
Saedi N, Metelitsa A, Petrell K, Arndt KA, Dover JS. Treatment of tattoos with a picosecond alexandrite laser: a prospective trial. Arch Dermatol. 2012 Dec;148(12):1360-3. doi: 10.1001/archdermatol.2012.2894. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Global percentage of tattoo clearance | Global percentage of tattoo clearance as assessed by blinded evaluators based on comparing pre and post treatment photos. | 8 weeks post final treatment | |
Secondary | Rate of tattoo clearance | Average number of treatments determined to achieve 50 and 75 percent clearance | 8 weeks post final treatment | |
Secondary | Adverse event reporting | Based on rate and severity of treatments with the PicoWay laser treatment | Through study completion, average of 1 year |
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