OBJECTIVE: We performed a randomized, paired, double-blind trial involving 14 participants with self-declared normal skin and 15 participants with self-declared sensitive skin to test the cutaneous compatibility of materials of low irritation potential for skin irritation (sanitary pads) elicited by repetitive topical application. METHODS: Two test products patches and two control substance patches were applied to the lateral aspect of the upper arm once daily under fully occlusive conditions for 4 days. The positive control patch was moistened with sodium lauryl sulphate (0.1% w/v) and the negative control patch was moistened with 0.9% sodium chloride, as were the two test material patches. The patches were removed, skin irritation (erythema) graded, and new patches applied after each 24-hour period. RESULTS: There was no significant difference in skin irritation from the test patches between the sensitive and normal skin groups. The two test patches and the negative control patch were significantly less irritating than the positive control in both test groups. Both test patches were comparable to the negative control patch in the normal and sensitive skin groups. CONCLUSION: The test materials produced similar degrees of skin irritation among both groups. Overall, there was no statistically significant difference in skin compatibility when the two feminine hygiene product test patches were worn by self-declared normal and sensitive skin groups.
RCT Entities:
OBJECTIVE: We performed a randomized, paired, double-blind trial involving 14 participants with self-declared normal skin and 15 participants with self-declared sensitive skin to test the cutaneous compatibility of materials of low irritation potential for skin irritation (sanitary pads) elicited by repetitive topical application. METHODS: Two test products patches and two control substance patches were applied to the lateral aspect of the upper arm once daily under fully occlusive conditions for 4 days. The positive control patch was moistened with sodium lauryl sulphate (0.1% w/v) and the negative control patch was moistened with 0.9% sodium chloride, as were the two test material patches. The patches were removed, skin irritation (erythema) graded, and new patches applied after each 24-hour period. RESULTS: There was no significant difference in skin irritation from the test patches between the sensitive and normal skin groups. The two test patches and the negative control patch were significantly less irritating than the positive control in both test groups. Both test patches were comparable to the negative control patch in the normal and sensitive skin groups. CONCLUSION: The test materials produced similar degrees of skin irritation among both groups. Overall, there was no statistically significant difference in skin compatibility when the two feminine hygiene product test patches were worn by self-declared normal and sensitive skin groups.