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OBJECTIVES: The aim of this study was to evaluate potential skin sensitization of the proteoglycan (PG) facial mask.
MATERIAL AND METHODS: 140 volunteers were recruited. The human repeated insult patch test (HRIPT) was used to assess skin sensitization and the potential of the proteoglycan (PG) facial mask. The test article material was 0.3 ml and the size was 1x1 cm2 per patch test. The placebo patch tests were applied on normal skin at left scapula area and applied PG facial mask patch tests on the right scapula area. In the induction phase, healthy volunteers applied patch tests on Monday, Wednesday, and Friday for three consecutive weeks. All of the patch tests were removed 24 hours (h) after having been applied and HRIPT scoring 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 having been applied and the experiment monitor presented at the 72 h reading of the HRIPT score.
RESULTS: All 140 volunteers completed the study. Age of subjects ranged from 19 to 26 years old (mean age 21.59 ± 1.90 years). The HRIPT scoring scale of induction phase and challenge phase, edema, papules, vesicles, and bullae of healthy volunteers applied with the PG facial mask were not significantly different when compared to the placebo patch test group.
CONCLUSION: This study has demonstrated that PG facial mask has low skin sensitization potential among healthy volunteers.
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