Healthy Clinical Trial
Official title:
A Prospective, Open Label, Non Randomized, First-In-Man (Feasibility) Study to Evaluate the Safety and Effectiveness of the Eraser Tattoo Removal Device
A new mechanical device is evaluated for tattoo removal, comparing two types of needle washing fluids. 30 healthy subjects with tattoos will be treated. The study hypothesis is that the device can be used to achieve satisfactory tattoo removal.
The new device (Eraser TM) uses multiple needles action with a washing fluid to remove
tattoos. Healthy patients who wish to remove a tattoo will be enrolled. The study will test
the removal of a small part of the tattoo (5cm2 area). Treatment lasts about 20 minutes
(with local analgesia if needed), after which an absorptive bandage is put over the treated
area for an hour and removed. Treatment may be performed using one of two washing fluids.
For one of them, blood samples for material blood level will be taken before and several
times after treatment. Pictures of the tattooed area being removed will be taken before and
after treatment, and at each follow-up evaluation.
Follow up evaluations will be performed at 1 week, two weeks, one month and two months post
treatment. Overall health and skin condition will be evaluated, and the tattoo area will be
pictured. Efficacy of tattoo removal will be evaluated after two months, by visual
estimation of the percent area that reacted to treatment, and the change in brightness (both
evaluated on a 1-5 analog scale). Depending on the result of tattoo removal, and on skin
condition, the study treatment will be stopped (if treatment is successful), or may be
repeated (up to a limit of two additional times) if the tattoo was not completely removed.
The results of tattoo removal using both washing fluids will be analyzed and compared. A
result of 3 or more on the brightness change scale will be considered as a successful
treatment.
Pharmacokinetic data for washing fluid no. 2 will be collected and analyzed, to provide Cmax
and AUC.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
| Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
| Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
| Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
| Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
| Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
| Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
| Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
| Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
| Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
| Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
| Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
| Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
| Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
| Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
| Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |