Tolerability of hair cleansing conditioners: a double-blind randomized, controlled trial designed to evaluate consumer complaints to the U.S. Food and Drug Administration

Warshaw, Erin M.; Schlarbaum, Jamie P.; Liou, Yujie Linda; Kimyon, Rebecca S.; Zhang, Amy J.; Nikle, Anne B; Monnot, Andrew D.; Hylwa, Sara

doi:10.1080/15569527.2020.1722154

Cited by 4 publications

(5 citation statements)

References 49 publications

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“…Although scalp dermatitis is strongly associated with HCP allergens, it is not the most common site (21.7% scalp vs 50.1% face). Because of enhanced tolerance, the scalp is less commonly affected in ACD, possibly because of protective sebum and/or moderation by local regulatory T cells, 20 which are concentrated in hair follicles 21,22 . Although facial dermatitis due to skin care products, such as moisturizers, makeup, sunscreen, and facial cleansers, has been well documented, 10 it is less commonly reported in relation to HCPs.…”

Section: Discussionmentioning

confidence: 99%

“…Because of enhanced tolerance, the scalp is less commonly affected in ACD, possibly because of protective sebum and/or moderation by local regulatory T cells, 20 which are concentrated in hair follicles. 21,22 Although facial dermatitis due to skin care products, such as moisturizers, makeup, sunscreen, and facial cleansers, has been well documented, 10 it is less commonly reported in relation to HCPs. This may be due to a "rinse-off" pattern of dermatitis for shampoo/conditioner, permanent wave, and dye allergy 23 and/or the preferential use of hairstyling products on the distal end of hair, which then may contact the face/neck/shoulders.…”

Section: Demographics and Site Involvementmentioning

confidence: 99%

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Contact Dermatitis Associated With Hair Care Products: A Retrospective Analysis of the North American Contact Dermatitis Group Data, 2001–2016

et al. 2021

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Background: Hair care products (HCPs) may cause both allergic contact dermatitis (ACD) and irritant contact dermatitis (ICD). Objectives: The aims of the study were to determine the prevalence of HCP-associated ICD/ACD and to characterize relevant allergens.Methods: This study is a retrospective analysis of North American Contact Dermatitis Group (NACDG) patch test data, 2001-2016.Results: Of 38,775 patients tested, 3481 (9.0%) had positive patch test reactions associated with HCPs. The HCP-positive patients were significantly more likely to be female (79.9% vs 66.0%) and/or have primary sites of dermatitis on the face (32.0% vs 27.8%) or scalp (15.4% vs 2.2%) compared with the HCP-negative patients (P < 0.0001). Of 4908 HCP-associated positive patch test reactions, 86.9% (n = 4263) were due to allergens on the NACDG screening series; p-phenylenediamine (35.8%), methylisothiazolinone (9.7%), methylchloroisothiazolinone/methylisothiazolinone (8.7%), and cocamidopropyl betaine (5.9%) were the most frequent. Most reactions (87.7%, 3736/4263) were currently clinically relevant. The most common job associated with 366 occupationally related NACDG HCP-associated allergens was hairdresser/cosmetologist (71.9%). Two hundred eighty-two patients (0.7%) had ICD associated with HCPs. Shampoo/conditioners were the most frequent source of NACDG HCP-associated reactions (47.3%) and HCP-associated ICD (45.0%).Conclusions: Of the HCP-positive patients, 18.5% had HCP reactions to allergens not on the NACDG screening series, underscoring the importance of patch testing to expanded series in patients suspected of HCP allergy.

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Section: Discussionmentioning

confidence: 99%

Section: Demographics and Site Involvementmentioning

confidence: 99%

Contact Dermatitis Associated With Hair Care Products: A Retrospective Analysis of the North American Contact Dermatitis Group Data, 2001–2016

et al. 2021

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“…Similarly, the application of WCD directly to 200 human volunteers in the form of repeat open application and patch test study did not lead to a skin sensitisation response. 28 Given the agreement of the aforementioned results, it is unlikely that users of the tested products will experience a skin sensitisation reaction. Although the findings from this study suggest that this testing strategy may serve as a good screening tool, further testing with a wider range of products, including confirmed positive and negative products, all at a range of dilutions, is necessary to validate this strategy and to determine its utility.…”

Section: Discussionmentioning

confidence: 81%

“…The results of this study are in agreement with other studies performed on the WCD cleansing conditioners. 28 In addition, in a robust in vitro human peripheral blood mononuclear cell and skin explant model previously demonstrated to be highly specific and sensitive when compared to the LLNA, our group found that treatment of up to 0.001% WCD cleansing conditioner did not lead to a skin sensitisation response (see Monnot AD, Towle KM, Ahmed SS, et al An in vitro human assay for evaluating immunogenic and sensitization potential of a personal care and cosmetic product. In submission).…”

Section: Discussionmentioning

confidence: 91%

Devising a Tier-based Skin Sensitisation Screening Strategy for Personal Care and Cosmetic Products

Fung¹,

Towle

Monnot

2020

Altern Lab Anim

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Concerns regarding the use of potential skin sensitisers in personal care and cosmetic products continue to grow. The goal of this study was to develop a proof-of-concept tier-based screening strategy for the assessment of skin sensitisation potential by using non-animal methodologies. As a case example, this screening framework was applied to three WEN® by Chaz Dean cleansing conditioners. The first tier of testing utilised the Organisation for Economic Co-operation and Development (OECD) Quantitative Structure Activity Relationship Toolbox profiler to evaluate the skin sensitisation potential of individual ingredients within the formulation; a literature review was performed on the substances that generated in silico alerts. Tier 2 testing utilised the OECD in chemico Test Guideline (TG) 442C to evaluate these substances. Tier 3 testing adapted OECD TG442C to evaluate the formulated product. The literature review on the four substances that generated in silico alerts revealed that they were not sensitising at the concentrations reported in the formulated products. Tier 2 testing demonstrated that these substances were not sensitising at the concentrations tested. Finally, Tier 3 testing revealed that the evaluated cleansing conditioners had low mean percentage peptide depletion at the concentrations tested. Together, the results obtained suggest that the products tested are unlikely to induce skin sensitisation under the given experimental conditions. These findings are in agreement with other in vitro and clinical studies. The proposed tier-based testing approach may be used as a conceptual framework for the prospective safety screening of other personal care and cosmetic products. However, to establish the validity of the proposed testing strategy, further studies must be performed, including comparisons with established models.

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“…Furthermore, while the variability within the exploratory assays is unclear, the results are in agreement with findings from evaluations of the same product by using other established in vitro and clinical studies. [23][24][25][26] Only one test article was evaluated in this current exploratory study; the evaluation of additional products would bolster the validity of the employed assays. While the sample size (e.g.…”

Section: Discussionmentioning

confidence: 99%

Evaluating the Impact of Hair Care Product Exposure on Hair Follicle and Scalp Health

Fung,

Parker,

Monnot

2023

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Human hair follicles traverse the epidermis and dermis, and are comprised of specialised cells including dermal papilla cells (DPCs). DPCs play a critical role in the development and growth of both hair and follicle structure. While exposure of DPCs to undiluted exogenous compounds is unlikely, exposure to diluted compounds is possible should dermal penetration occur. The goal of this study was to evaluate the impact on hair and scalp health following application of a hair care product. Due to the lack of standardised and validated test systems for evaluating hair follicle health, the HairSkin® model, which uses intact human scalp samples, was adapted to evaluate hair follicle and scalp health. Similarly, the Franz diffusion cell assay and matrix-assisted laser desorption ionisation-Fourier transform ion cyclotron resonance (MALDI-FTICR) were adapted to evaluate dermal penetration. The results of this study demonstrate that application of the hair care product does not result in appreciable dermal penetration, suggesting that DPCs are unlikely to be exposed to undiluted product. Additionally, hair follicle health was not impacted following product application. While this study is exploratory, these results suggest that the combination of test systems utilised herein provides valuable insight and warrants further development and validation.

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Tolerability of hair cleansing conditioners: a double-blind randomized, controlled trial designed to evaluate consumer complaints to the U.S. Food and Drug Administration

Cited by 4 publications

References 49 publications

Contact Dermatitis Associated With Hair Care Products: A Retrospective Analysis of the North American Contact Dermatitis Group Data, 2001–2016

Contact Dermatitis Associated With Hair Care Products: A Retrospective Analysis of the North American Contact Dermatitis Group Data, 2001–2016

Devising a Tier-based Skin Sensitisation Screening Strategy for Personal Care and Cosmetic Products

Evaluating the Impact of Hair Care Product Exposure on Hair Follicle and Scalp Health

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