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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT03866304
Eligibility Criteria:
Inclusion Criteria:
* Healthy female and male subjects between 18 to 65 years of age
* Fitzpatrick Skin Type I - VI
* Have unwanted decorative (non-cosmetic) tattoo(s) and willing to undergo laser treatments to remove them
* Have a tattoo contains containing single or multi-color ink.
* Willing to receive the proposed S2 laser treatments and comply with study (protocol) requirements
* 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.
* Agree not to undergo any other procedure(s) for the tattoo removal during the study.
Exclusion Criteria:
* Participation in a study of another device or drug within 6 months prior to enrollment or during the study.
* Pregnant or planning to become pregnant, having given birth less than 3 months prior to treatment, and/or breastfeeding
* History of allergic reaction to pigments following tattooing.
* History of hypersensitivity to light exposure
* Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
* History of malignant tumors in the target area.
* 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 or during the treatment course
* Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
* History of keloid scarring, abnormal wound healing and / or prone bruising
* Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
* Suffering from coagulation disorders or taking prescription anticoagulation medications.
* History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
* History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
* History of vitiligo, eczema, or psoriasis.
* History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
* History of seizure disorders due to light.
* Suffering from Histoplasmosis, hyperparathyroidism, Lymphoma, kidney disease, sarcoidosis, tuberculosis, high levels of calcium in the blood
* Suffering from Vitamin D deficiency
* 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:
65 Years
Study:
NCT03866304
Study Brief:
Protocol Section:
NCT03866304