CHLOROMETHYLISOTHIAZOLONE METHYLISOTHIAZOLONE (CMI/MI) USE TEST WITH A SHAMPOO ON PATCH-TEST-POSITIVE SUBJECTS - RESULTS OF A MULTICENTER DOUBLE-BLIND CROSSOVER TRIAL

A randomized, multicentre, double-blind, 2-period crossover study with 2 shampoos was performed on subjects patch-test-positive to 100 ppm CMI/MI. One shampoo was preserved with 15 ppm a.i. CMI/MI, the other with 0.3% imidazolidinyl urea (IU). 27 subjects from 5 European dermatology clinics participated. 1 subject discontinued use after severe adverse reactions to the CMI/MI-preserved shampoo and did not evaluate the other shampoo. Another 2 subjects developed moderate symptoms with the CMI/MI-preserved shampoo and discontinued its use, but tolerated the IU-preserved shampoo for the full 2-week period. 2 subjects discontinued use after 1 or 2 washes after severe adverse reactions to the IU-preserved shampoo. 1 of these subjects tolerated the CMI/MI-preserved shampoo for 2 weeks without any untoward effects. However, the majority of subjects had negative findings on the scalp, face, neck, and hands for both shampoos. The physicians' global evaluation data indicated that shampoo with CMI/MI caused fewer skin problems than shampoo with IU (38% versus 27%, n.s.), with over 1/3 of the subjects (35%) having no skin problems with either preservative. The current study showed that most subjects previously sensitized to CMI/MI can successfully use shampoo preserved with CMI/MI. Since some subjects previously sensitized to CMI/MI, or possibly to IU, may develop clinical reactions, it would still be prudent for the clinician to advise alternative products to patients with sensitivity to a shampoo or cosmetic ingredient. Full ingredient labelling will ensure that this is possible. As the overall rate of adverse effects in sensitized individuals was low, studies of this nature should also be conducted for other allergens. This will be helpful in determining the relevance of patch test data.