Multicenter clinical trial on a permanent hair dye containing paratoluenediamine

BACKGROUND: Adverse reactions to hair dyes are frequent and usually caused by sensitization to paraphenylenediamine (PPD). The aim of the study was to evaluate the tolerability of a PPD-free permanent hair dye (Shine On, BioNike, Milan, Italy) containing paratoluenediamine (PTD) in a group of subjects sensitized to PPD. METHODS: The trial, which carried out at four dermatology centers, included subjects sensitized to PPD that turned out negative to patch testing to PTD. The subjects underwent to an open test consisting in the application of two hair dye colors of the product under examination. Finally, subjects who were negative upon the open test were offered to undergo the usage test with the dye, with dermatological evaluations carried out 48 and 96 hours after product application. RESULT S: Sixty subjects were enrolled. They underwent the open test with two shades of dyes: "color 1 - black," the dye color with the highest concentration of color intermediates, and "color 7.3 - golden blonde," the dye color with the highest number of chemically different color intermediates. No reactions occurred with "color 7.3 - golden blonde," while 3 cases (3 out of 60) showed erythema and edema reactions to color 1. The hair dye usage test was negative for all the 21 subjects that were enrolled. CONCLUSIONS: The hair dye evaluated in this study (Shine On, BioNike) can be a valid alternative for subjects sensitized to PPD.