English term or phrase: human repeat insult patch test This human repeat insult patch test was conducted for x Inc to assess the potential of the Sponsor’s test material. Mitted the production of highly specific anti-human IgE an- tibodies. Repeat insult patch test (RUT), the 4-day semiocclusive patch test, and an.
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Introduction: The Cussons Baby Sensicare Range is a newly developed set of products specially formulated for newborn, sensitive and eczema prone skin. As such, these products need to be tested to evaluate their skin irritation and sensitization potential before use. The products were evaluated with two separate tests. The first test was conducted in a single-center, within-subject comparison using assessor-blind, randomised human skin irritation patch test (48 hour/96 hour exposure) and conducted on healthy adults with sensitive, atopic skin. The second test was conducted in a single-center, controlled (sterile water), within subject using human repeat-insult patch tests (HRIPTs) and conducted on healthy female Indonesian and Asian adult female subjects, with sensitive skin.
The sensitization potential of each product was determined from International Contact Dermatitis Research Group (ICDRG) scores at 30 minutes, 24 hours, 48 hours and 72 hours after patch removal. Skin irritation tests show that all products were significantly lower than the positive control sodium lauryl sulphate (SLS) (p. IntroductionContact sensitization is a process whereby the host (through prior skin exposure) acquires a specific, increase sensitivity (reactivity) to a substance upon subsequent exposure. Whereas reactions may be minimal or absent upon the first contact, the skin responds to subsequent applications in a heightened manner. The reaction may range in severity from a minor annoyance of transient redness and itching, to a severe, widespread and possibly disabling eczematous eruption. It is important that new cosmetic products are tested to evaluate their skin irritation and sensitization potential.The Cussons Baby Sensicare Range (PZ Cussons, Indonesia) is a new specially developed range of products for newborn, sensitive and eczema prone skin. Baby skin differs from adult skin and requires special care 1 2.
The products are based on a Triple Protection Complex consisting of avena sativa (oat) extract, olea Europaea (olive) fruit oil and ceramides; ingredients selected for their dermocosmetic properties (moisturization, barrier protection, anti-inflammatory, antioxidant and soothing effects). Oats have been used for a long time to alleviate itching and irritation 3 and avena sativa has been shown to have preventive effects on skin irritation in a SLS model 4. Olive oil’s composition is similar to that of sebum which makes it particularly able to protect the skin 5. Ceramide 3 has been shown to have a protecting effect against surfactant-induced dermatitis 6.
In order to determine the hypoallergenicity and skin irritation potential of the Cussons Baby Sensicare range of products a human repeat insult patch test (HRIPT) and human skin irritation patch test were conducted in adult volunteers.2. Test ProductsCommercially available product provided by PZ Cussons Indonesia was investigated in these studies. Cussons Baby Sensicare Gentle Hair and Body Wash is a surfactant base with Dermasoft TM Complex and Argania spinosa (Argan) kernal oil. The Cussons Baby Sensicare 24 hr Daily Moisturizing Lotion and Cussons Baby Sensicare Intensive Soothing Cream are oil in water emulsion with Dermasoft TM Complex and Butyrospermum parkii (Shea) Butter.
Detail of ingredients list of Cussons Baby Sensicare Range provided in.2.2. Skin Irritation Potential (48/96 h Single Patch Test)This was a single-centre, within-subject comparison, assessor blinded, randomised study conducted by Alba Science Ltd in 26 healthy volunteers, male and female aged 18 to 70 who had self-assessed sensitive, atopic skin (assessed by completion of a questionnaire). Ingredients list cussons baby sensicare.The Cussons Baby Sensicare Gentle Hair & Body Wash was assessed over 48-hour exposure with 2 consecutive 23-hour patch applications of 2.0% concentration. Cussons Baby Sensicare 24 hours Daily Moisturizing Lotion and the Cussons Baby Sensicare Intensive Soothing Cream were assessed over 96-hour exposure with 4 consecutive 23-hour patch applications. SLS (0.3% w/v) and sterile water were included as controls.The application area for the test and control products was the upper, outer arms. A randomised product application schedule was generated for each subject to randomly allocate each product to an application site. The order of products in the patch schedule was randomised to eliminate position and order bias.Approximately 20 µl of each product and control was applied to the skin under an occlusive patch (Finn Chamber 8 mm).
Skin markers marked either end of the Finn Chamber to allow exact relocation to the test areas at subsequent applications. Approximately 23 hours after application the subjects removed their patch and washed the test sites to remove residual test and control material. The test sites were assessed approximately 1 hour later by a trained assessor, following the scoring system detailed in. After assessment, an identical patch was reapplied to the same area for a further period of approximately 23 hours. The test and control materials were reapplied to the same sites as before, following assessment. Any test or control material which elicited erythema or dryness with a score of 5 or more was not reapplied. Any test or control material which elicited a palpable response was not reapplied.
Scoring scale wet used during study skin irritation potential.For the 48 h test materials, treatment was over 3 consecutive days, commencing on Day 1 when the test materials were applied as described. The test materials were applied on Days 1 and 2. Skin assessments were on Days 2 and 3.
The paediatric consultant was present for skin assessments on Day 3.For the 96 h test materials, treatment was over 5 consecutive days, commencing on Day 1 when the test materials were applied as described. The test materials were applied on Days 1, 2, 3 and 4. Skin assessments were on Days 2, 3, 4 and 5. The paediatric consultant was present for skin assessments on Day 5.Erythema, Dryness and Irritation scores are ordinal categorical measurements taken repeatedly on volunteers, so multinomial models coupled with Generalised Estimating Equations (GEEs) were fitted. This method accommodates both the ordinal categorical nature of the response scores and potential correlated errors within subjects. Only the responses at 48h and 96h were considered.Multiple-comparison adjustments were made to significance levels, where appropriate, to maintain a nominal family-level type I error rate of 5%. All analysis was conducted in SASV 9.4 and RV 3.2.2.3.
Skin Sensitization Potential (Human Repeat Insult Patch Test, HRIPTs)One hundred (100) healthy female Indonesian and Asian subjects, aged 18 - 55 years old with sensitive skin and uniform pigmentation on the test area were required for study entry. Selection of subjects with sensitive skin was based on a positive skin reaction to a 1% closed patch test with sodium lauryl sulphate (SLS) for 24 hours.The studies were controlled, within subject, human repeat-insult patch tests (HRIPT) conducted by Assertra Inno Medikos Dermatology Laboratory in Indonesia. Each product (about 20 µl) was applied under an occlusive patch (Finn Chamber 8 mm (50 mm 2)) to intact skin on the back of each volunteer every other day for 3 weeks (Induction Phase). The subjects then had a 2 week Rest Phase before the Challenge Phase when subjects were patched again for 24 hours to a previously untreated skin site. An overview of the product application in the RIPTs is provided in. ICDRG criteria for assessing sensitization potential during challenge phase of repeat-insult patch test.ICDRG = International Contact Dermatitis Research Group.3.
Skin Irritation PotentialTwenty-nine subjects with self-assessed sensitive, atopic skin were recruited for the study and 27 subjects were screened. Of these, 26 subjects participated in and completed the study (10 males and 16 females). The mean age of study participants was 39.4 years (range 19 - 63 years). The total means of irritation scores (erythema and dryness) are presented in.
All products were significantly lower than the positive control (p. ICDRG criteria for assessing sensitization potential during challenge phase of repeat-insult patch test.SLS = sodium lauryl sulphate.3.2. HRIPTOne hundred and forty-five (145) subjects were evaluated with the 1% closed patch test with SLS.
From these subjects one hundred and eleven (111) subjects were selected to enter the study, having confirmed sensitive skin. There were seven (7) dropouts and one hundred and four (104) subjects completed the study. The average age of study participants was 34.8 years (range 18 - 53 years).The Cussons Baby Sensicare Gentle Hair and Body Wash was found to be slightly irritating during the Induction Phase of the RIPT (MCII = 0.183) and non-sensitizing (reaction was only very slight erythema in 23/104 subjects with no persist oedema or infiltration reactions noted). The Cussons Baby Sensicare 24 hours Daily Moisturizing Lotion was found to be very slightly irritating during the Induction Phase of the RIPT (MCII = 0.097) and non-sensitizing (reaction was only very slight erythema in 18/104 subjects with no persist oedema or infiltration reactions noted).
The Cussons Baby Sensicare Intensive Soothing Cream was found to be very slightly irritating during the Induction Phase of the RIPT (MCII = 0.078) and non-sensitizing (reaction was only very slight erythema in 12/104 subjects with no persist oedema or infiltration reactions noted). Results are summarised in. Overview of HRIPT results.ICDRG = International Contact Dermatitis Research Group; MCII = Mean Cumulative Irritation Index; HRIPT = Human Repeat Insult Patch Test.4. DiscussionThe Skin Irritation Patch Test (48 h/96 h Exposure) in a panel of healthy subjects who have self-assessed sensitive, atopic skin is used to assess the primary skin irritation potential of Cussons Baby Sensicare products when applied cutaneously to subjects. The aim of this study was to substantiate the claims of “Dermatologically Tested and Approved”, “Suitable for Sensitive Skin”, “Suitable for Eczema Prone Skin” and “Paediatrician Approved” for each test material. Assessments were confirmed by a dermatologist and Paediatrician.The test products were well tolerated during the study, producing low levels of irritation.
All 96h test Products (Cussons Baby Sensicare 24 hours Daily Moisturizing Lotion and the Cussons Baby Sensicare Intensive Soothing Cream) were significantly lower than the positive control in terms of erythema, dryness and irritation level (p.
Background:
Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing. Failure to adequately substantiate the safety of a cosmetic product or its ingredients prior to marketing causes the product to be misbranded unless the following warning statement appears conspicuously on the principal display panel of the product's label: 'Warning--The safety of this product has not been determined.' (21 CFR 740.10) In addition, regulations prohibit or restrict the use of several ingredients5 in cosmetic products and require warning statements6 on the labels of certain types of cosmetics.
In general, except for color additives and those ingredients which are prohibited or restricted from use in cosmetics by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic provided that the ingredient and the finished cosmetic are safe, the product is properly labeled, and the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.
Ref: http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074162.htm
Human Repeat Insult Patch Test (HRIPT)–Sensitization, Allergic Response
Sensitization is the process by which humans can develop over time increased allergic responses to a substance through repeated exposure to that substance. It is different from irritation because it involves the immune response. Due to immune response, the reaction becomes worse with repeated exposure, and it is usually specific to individuals. The HRIPT consists of 2 phases, and sometimes 3.
Phase I is the Induction Phase where the product is applied to the skin 9 times during the course of 3 weeks. This is followed by a two-week rest period after which the skin is exposed to the product again in Phase II or the Elicitation Phase. A response in Phase II is usually allergic in nature and Phase III is used to verify and better define the reaction. There are different methods that are available which have different application phases but the resulting predictions of allergy and irritation response are the scientific goals. The industry standard for these tests is usually to use a minimum of 50 human volunteers. However, up to 200 subjects is sometimes used for better statistical prediction. Dermatologist involvement in these studies as signatory or Primary Investigator is also offered. Safe for Sensitive Skin is a common claim whereby subjects are recruited that either have self perceived sensitive skin or test positive using the lactic acid sting test.
Other tests available:
Phase I (Cutaneous Safety Tests) ![]()
Photosensitization Photosensitization can occur when normally harmless molecules undergo changes when exposed to UV light. The HRIPT method is modified in combination with exposure to UV-A irradiation to determine the phototoxic or photoallergic potential of a topically applied product. ![]() Comments are closed.
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