HYPRSKN / Safety
The Ten of Hearts Study
The Ten of Hearts Study Results from MUDGIL Dermatology
Ten of Hearts Study Discussion:
The unique design of this study, namely, enabling a direct comparison of one’s response to Magic Ink and conventional tattoo ink in the same recipient at identical anatomic tattoo locations, allows the safety and tolerability of Magic Ink in the immediate post-tattoo placement period to be determined. With any tattoo site, regardless of the specific type of pigment placed, some degree of tenderness, swelling, redness and itch can be expected. This is considered part of the “normal” tattoo healing process. All of the reactions reported, whether being reported by the subjects themselves or detected on clinical examination, fell within this norm.
Magic Ink and conventional ink tattoos were exceedingly well tolerated in all recipients, with the vast majority of tattoo recipients not experiencing any reaction to either ink. In the small minority of recipients reporting a reaction, these were minor in nature, fell well within the realm of “normal” tattoo healing, and were equally distributed between conventional ink and Magic Ink tattoo sites. Moreover, any reactions were all short-lived in nature, resolving within the first week or so. An additional note is the apparent shared efficacy in darker-complected individuals; three of the recipients have skin type III-IV. There was no difference in behavior noted with either Magic Ink or conventional tattoo ink in these individuals when compared to recipients with fairer skin over the 21 day follow-up period.
Based on the data obtained, it can be confidently concluded that Magic Ink tattoos behaved equally and were tolerated as well as conventional ink tattoos.
Adarsh Vijay Mudgil, M.D.
Study Background/Purpose/Design:
Magic Ink is the world’s first rewritable tattoo ink. This novel ink enables one to seemingly magically alter the appearance of their tattoo using an ultraviolet light source. The primary difference between Magic Ink and conventional tattoo inks are its proprietary smart nano-pigments, which are embedded in polymethylmethacrylate (PMMA), a synthetic, biologically inert polymer widely and safely used in medicine and dentistry for various indications for many decades.
The purpose of this study was to compare the behavior of Magic Ink to conventional tattoo ink in ten subjects to evaluate/support its safety and tolerability.
To accomplish this, subjects received a heart-shaped tattoo using Magic Ink; an identical heart-shaped tattoo was placed on the exact opposing anatomic location using the same colored conventional tattoo ink (i.e. Magic Ink right wrist/conventional ink left wrist, Magic Ink right inner ankle/conventional ink left inner ankle etc.). Photographs of both tattoo sites were collected on days 1-7, and on days 14 and 21. In addition, a survey querying subjects regarding any pain, itch, and/or redness was collected daily on days 1-7. Last, a clinical evaluation for erythema, swelling, scale/crust, and tenderness of both tattoo sites in each individual was performed by a board certified dermatologist on days 7 and 21.
Ten of Hearts Study Results:
There were two primary sets of data outcomes collected. The first was subject reported, and collected on days 1-7, assessing for any pain, redness, or itch at both tattoo sites. The second was collected on days 7 and 21 by a board certified dermatologist assessing for erythema, swelling, scale/crust, and tenderness.
In the subject reported data, 94% of responses indicated zero pain, redness, or itch at either the Magic Ink tattoo or conventional ink tattoo sites. Of the remaining 6%, the outcomes were equally distributed; 2% reported experiencing more pain/redness/itch at the conventional ink tattoo site when compared to the Magic Ink tattoo site, 2% reported more pain/redness/itch at the Magic Ink tattoo site when compared to the conventional ink tattoo site; 2% reported equal pain/redness/itch at both tattoo sites.
An evaluation by a board certified dermatologist was performed on days 7 and 21 evaluating for erythema, swelling, scale/crust, and tenderness. On day 7, 89% of the subjects had zero reaction at either tattoo site. Of the remaining 11% the only reaction identified was “scale/crust,” which was more prevalent at Magic Ink tattoo sites relative to conventional ink tattoo sites. By day 21, 100% of recipients had zero reaction at either tattoo site.
MIST Study Results from MUDGIL Dermatology
Ten of Hearts Study Results:
There were two primary sets of data outcomes collected. The first was subject reported, and collected on days 1-7, assessing for any pain, redness, or itch at both tattoo sites. The second was collected on days 7 and 21 by a board certified dermatologist assessing for erythema, swelling, scale/crust, and tenderness.
In the subject reported data, 94% of responses indicated zero pain, redness, or itch at either the Magic Ink tattoo or conventional ink tattoo sites. Of the remaining 6%, the outcomes were equally distributed; 2% reported experiencing more pain/redness/itch at the conventional ink tattoo site when compared to the Magic Ink tattoo site, 2% reported more pain/redness/itch at the Magic Ink tattoo site when compared to the conventional ink tattoo site; 2% reported equal pain/redness/itch at both tattoo sites.
An evaluation by a board certified dermatologist was performed on days 7 and 21 evaluating for erythema, swelling, scale/crust, and tenderness. On day 7, 89% of the subjects had zero reaction at either tattoo site. Of the remaining 11% the only reaction identified was “scale/crust,” which was more prevalent at Magic Ink tattoo sites relative to conventional ink tattoo sites. By day 21, 100% of recipients had zero reaction at either tattoo site.
Ten of Hearts Study Discussion:
The unique design of this study, namely, enabling a direct comparison of one’s response to Magic Ink and conventional tattoo ink in the same recipient at identical anatomic tattoo locations, allows the safety and tolerability of Magic Ink in the immediate post-tattoo placement period to be determined. With any tattoo site, regardless of the specific type of pigment placed, some degree of tenderness, swelling, redness and itch can be expected. This is considered part of the “normal” tattoo healing process. All of the reactions reported,
whether being reported by the subjects themselves or detected on clinical examination, fell within this norm.
Magic Ink and conventional ink tattoos were exceedingly well tolerated in all recipients, with the vast majority of tattoo recipients not experiencing any reaction to either ink. In the small minority of recipients reporting a reaction, these were minor in nature, fell well within the realm of “normal” tattoo healing, and were equally distributed between conventional ink and Magic Ink tattoo sites. Moreover, any reactions were all short-lived in nature, resolving within the first week or so. An additional note is the apparent shared efficacy in darker-complected individuals; three of the recipients have skin type III-IV. There was no difference in behavior noted with either Magic Ink or conventional tattoo ink in these individuals when compared to recipients with fairer skin over the 21 day follow-up period.
Based on the data obtained, it can be confidently concluded that Magic Ink tattoos behaved equally and were tolerated as well as conventional ink tattoos.
Regards,
Adarsh Vijay Mudgil, M.D.
To Whom it May Concern:
What follows is a summary of the HYPRSKN Ten of Hearts study. Study Background/Purpose/Design:
Magic Ink is the world’s first rewritable tattoo ink. This novel ink enables one to seemingly magically alter the appearance of their tattoo using an ultraviolet light source. The primary difference between Magic Ink and conventional tattoo inks are its proprietary smart nano-pigments, which are embedded in polymethylmethacrylate (PMMA), a synthetic, biologically inert polymer widely and safely used in medicine and dentistry for various indications for many decades.
The purpose of this study was to compare the behavior of Magic Ink to conventional tattoo ink in ten subjects to evaluate/support its safety and tolerability.
To accomplish this, subjects received a heart-shaped tattoo using Magic Ink; an identical heart-shaped tattoo was placed on the exact opposing anatomic location using the same colored conventional tattoo ink (i.e. Magic Ink right wrist/conventional ink left wrist, Magic Ink right inner ankle/conventional ink left inner ankle etc.). Photographs of both tattoo sites were collected on days 1-7, and on days 14 and 21. In addition, a survey querying subjects regarding any pain, itch, and/or redness was collected daily on days 1-7. Last, a
clinical evaluation for erythema, swelling, scale/crust, and tenderness of both tattoo sites in each individual was performed by a board certified dermatologist on days 7 and 21.