Evaluation of Potential Skin Sensitization of Humans Receiving Bright and Firm Hybrid Emulsion I
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Abstract
MATERIAL AND METHODS: 130 subjects were recruited and the human repeated insult patch test (HRIPT) was used to assess the skin sensitization potential of the Bright and Firm Hybrid Emulsion I. The test article container was 0.2 g and the size per patch test was 2x2 cm2. The placebo patch tests were applied on normal skin at the right scapula area and Bright and Firm Hybrid Emulsion I patch tests were applied on the left scapula area. In the induction phase, subjects applied patch tests on Monday, Wednesday, and Friday for three consecutive weeks. All of the patch tests were removed 24 hours (h) after being applied and the HRIPT score was evaluated. After the induction phase, a single challenge patch was applied to a naïve site of normal skin. The challenge phase is scored 24, 48, and 72 h after application and the experiment was monitored at the 72 h HRIPT score reading.
RESULT: All 130 subjects completed the study. The age of subjects ranged between 19 to 33 years old (mean age 21.45 ± 1.45 years). The HRIPT scoring scale was measured for to the induction and challenge phase, edema, papules, vesicles, and bullae of the subjects who applied Bright and Firm Hybrid Emulsion I. The results were not significantly different when compared to the placebo patch test group.
CONCLUSION: This study shown that Bright and Firm Hybrid Emulsion I is a low skin sensitization potential among subjects.
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