Assessment of Irritation and Sensitization Potential of Eight Baby Skin Care Products
October 2016 | Volume 15 | Issue 10 | Original Article | 1244 | Copyright © October 2016
Carlos Galzote,a Mini Thomas PhD,b and Mukta Sachdev MDc
aJohnson & Johnson China Ltd., Shanghai, China bJohnson & Johnson Ltd., Mulund, Mumbai, India cMS Clinical Research Pvt. Ltd. Bangalore, India
BACKGROUND: Ethnic differences in skin sensitivity suggest that greater emphasis be focused on understanding a product’s effect in diverse populations.
OBJECTIVE: The irritation and/or sensitization potential of 8 baby skin care products in Indian adults were evaluated using cumulative irritation tests (CIT) and human repeat insult patch testing (HRIPT) protocols.
PATIENTS/MATERIALS/METHODS: Healthy males or females aged 18 to 65 years of Indian ethnicity were treated with each of 6 products (cream, hair oil, lotion, body wash, shampoo, and baby soap) using CIT (n = 25) and HRIPT (n = 200). Baby powder and baby oil were evaluated by CIT (n = 25) and HRIPT (n = 107) in separate studies. CITs were conducted over 14 days; HRIPTs were conducted over 10 weeks.
RESULTS: In both CIT and HRIPT, most products were considered mild, with no irritation. Baby soap and powder elicited reactions in the HRIPT induction phase, with positive challenge phase reactions (3 subjects), but were affirmed to be nonallergenic in the rechallenge phase.
CONCLUSIONS: In these studies, 8 baby skin care products were evaluated by both CIT and HRIPT in Indian adults. The results of the studies indicated that all of the tested products were nonallergenic and nonirritating. J Drugs Dermatol.
Assessing the risk for skin irritation and sensitization is a critical step in the development of products designed for skin care.1-4 Ethnic differences in skin sensitivity have been investigated with varying results, suggesting that greater emphasis be focused on understanding a product’s effect in diverse populations.5-10Cumulative irritation testing (CIT) is used to evaluate irritation potential after skin is continuously exposed to a product for a defined period.4,11 The human repeat insult patch test (HRIPT) is used to evaluate potential skin sensitizers.2,3 In this test, subjects are exposed to a product and then, after a rest period, exposed again to determine whether a sensitivity reaction was elicited by the second exposure.The objective of these studies was to determine the irritation and/or sensitization potential of 8 baby skin care products in Indian subjects using both CIT and HRIPT methods.
MATERIALS AND METHODS
Four separate studies are included in this report: 2 CIT studies and 2 HRIPT studies. All 4 studies described were performed at MS Clinical Research, Bangalore, India and were registered in The Clinical Trials Registry - India (CTRI;http://ctri.nic.in/Clinicaltrials/). The studies had the following registration numbers: Study 1: CIT (2013)-CTRI/2013/12/004191; Study 2: HRIPT (2013)-CTRI/2014/01/004295; Study 3: CIT (2012)-CTRI/2013/01/003285; Study 4: HRIPT (2012)-CTRI/2013/02/003371. Each separate study was performed after obtaining ethical clearance in writing from an independent ethics committee (Clinicom, Bangalore, India). All subjects signed an informed consent document (consistent with the requirements of the US Food and Drug Administration’s informed consent elements document 21 Code of Federal Regulations 50.25).12
Inclusion CriteriaHealthy male or female subjects aged 18 to 65 years of Indian ethnicity were eligible to enroll. Subjects were required to be willing to avoid the use of other topical products to the test site during the study. In addition, they had to be willing to avoid direct sun exposure to their skin test sites and to avoid the use of tanning beds for the duration of the study.Exclusion CriteriaSubjects were excluded from the study if they had a history of psoriasis, active allergic skin responses, or active eczema. Subjects with sunburn, acne, abrasions, scar tissue, or tattoos