Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT02700932
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02700932
Study Brief:
Protocol Section:
NCT02700932