ABSTRACT
The Expert Panel for Cosmetic Ingredient Safety (Panel) first published the Final Report of the safety of Isobutane, Isopentane, Butane, and Propane in 1982. The Panel previously concluded that these ingredients are considered safe as cosmetic ingredients under the present conditions of concentration and use, as described in that safety assessment. Upon re-review in 2002, the Panel reaffirmed the original conclusion, as published in 2005. The Panel reviewed update frequency and concentration of use data again in 2023, in addition to newly available, relevant safety data. Considering this information, as well as the information provided in the original safety assessment and the prior re-review document, the Panel reaffirmed the 1982 conclusion for Isobutane, Isopentane, Butane, and Propane.
ABSTRACT
The Expert Panel for Cosmetic Ingredient Safety (Panel) first published a safety assessment of Sodium Dehydroacetate and Dehydroacetic Acid in 1985. The Panel previously concluded that Sodium Dehydroacetate and Dehydroacetic Acid are safe as used in the present practices of use and concentration, as stated in that report. Upon re-review in 2003, the Panel reaffirmed the original conclusion, as published in 2006. The Panel reviewed updated frequency and concentration of use data again in 2023, in addition to any newly available, relevant safety data. Considering this information, as well as the information provided in the original safety assessment and the prior re-review document, the Panel reaffirmed the 1985 conclusion.
ABSTRACT
Contact dermatitis (CD) is a common and burdensome condition divided into irritant contact dermatitis and allergic contact dermatitis. Treatment relies on accurate diagnosis and identification of the trigger, because definitive treatment is irritant or allergen avoidance. However, avoidance is not always possible, such as when the patient is reacting to a necessary medical device, when the trigger is integral to the patient's occupation, and when avoidance is practically untenable. In these cases, treatment is particularly challenging, especially because the literature on treatments in this clinical scenario is limited. In addition, CD has a complex pathophysiology that varies according to the trigger type, leading to variable treatment efficacy. This article reviews the current literature on treatments for CD with a focus on treatments when trigger avoidance is not feasible.
ABSTRACT
Importance: Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea. Objective: To develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice. Evidence Review: A systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set. Findings: The Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting. Conclusions and Relevance: This core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.
Subject(s)
Clinical Trials as Topic , Consensus , Delphi Technique , Rosacea , Rosacea/therapy , Rosacea/diagnosis , Humans , Clinical Trials as Topic/standards , Outcome Assessment, Health Care/standards , Treatment OutcomeABSTRACT
The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 1982 and a previous re-review in 2002, along with updated information regarding product types and concentrations of use. Considering this information, the Panel confirmed that Laneth-9 Acetate and Laneth-10 Acetate are safe for topical application to humans in the present practices of use and concentration as described in this report.
Subject(s)
Acetates , Cosmetics , Animals , Humans , Acetates/toxicity , Acetates/pharmacokinetics , Consumer Product Safety , Cosmetics/toxicityABSTRACT
The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 1986 and a previous re-review in 2004, along with updated information regarding product types and concentrations of use. Considering this information, the Panel confirmed that Zinc Phenolsulfonate is safe as a cosmetic ingredient in the present practices of use and concentration as described in this report.
Subject(s)
Cosmetics , Phenols , Sulfates , Zinc , Animals , Humans , Consumer Product Safety , Cosmetics/toxicity , Cosmetics/chemistry , Organometallic Compounds/toxicity , Risk Assessment , Toxicity Tests , Zinc/chemistry , Zinc/toxicity , Sulfates/chemistry , Sulfates/toxicity , Phenols/chemistry , Phenols/toxicityABSTRACT
The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Polysilicone-11 as used in cosmetic formulations. This ingredient is reported to function as a film former. The Panel considered the available data and concluded that Polysilicone-11 is safe in cosmetics in the present practices of use and concentration described in this safety assessment.
Subject(s)
Consumer Product Safety , Cosmetics , Cosmetics/toxicity , Cosmetics/chemistry , Humans , Animals , Risk Assessment , Toxicity Tests , Silicones/toxicity , Silicones/chemistryABSTRACT
The differential diagnosis of dermatoses in the axillae is broad. Contact dermatitis-both irritant and allergic-represents common etiologies. Axillary contact dermatitis can develop following exposure to a variety of irritants and/or allergens. Frequently implicated sources include deodorants, antiperspirants, detergents, soaps, and clothing. Fragrance, a ubiquitous ingredient within these products, as well as metals and dyes, are common causes of contact dermatitis. Clinical assessment, bedside diagnostic techniques, histopathology, and patch testing can aid in the diagnosis and help inform management directions.
Subject(s)
Dermatitis, Allergic Contact , Dermatitis, Irritant , Humans , Allergens/adverse effects , Dermatitis, Allergic Contact/diagnosis , Dermatitis, Allergic Contact/etiology , Dermatitis, Allergic Contact/therapy , Patch Tests , Dermatitis, Irritant/etiology , Diagnosis, DifferentialABSTRACT
BACKGROUND: For people with atopic dermatitis (AD) refractory to topical therapies, treatment with phototherapy and systemic therapies can be considered. Multiple biologic therapies and Janus kinase (JAK)inhibitors have been approved since 2014 to treat AD. These guidelines update the 2014 recommendations for management of AD with phototherapy and systemic therapies. OBJECTIVE: To provide evidence-based recommendations on the use of phototherapy and systemic therapies for AD in adults. METHODS: A multidisciplinary workgroup conducted a systematic review and applied the GRADE approach for assessing the certainty of evidence and formulating and grading recommendations. RESULTS: The workgroup developed 11 recommendations on the management of AD in adults with phototherapy and systemic agents, including biologics, oral JAK inhibitors, and other immunomodulatory medications. LIMITATIONS: Most randomized controlled trials of phototherapy and systemic therapies for AD are of short duration with subsequent extension studies, limiting comparative long-term efficacy and safety conclusions. CONCLUSIONS: We make strong recommendations for the use of dupilumab, tralokinumab, abrocitinib, baricitinib, and upadacitinib. We make conditional recommendations in favor of using phototherapy, azathioprine, cyclosporine, methotrexate, and mycophenolate, and against the use of systemic corticosteroids.
Subject(s)
Dermatitis, Atopic , Janus Kinase Inhibitors , Adult , Humans , Cyclosporine/therapeutic use , Dermatitis, Atopic/drug therapy , Immunosuppressive Agents/therapeutic use , Janus Kinase Inhibitors/therapeutic use , Methotrexate/therapeutic use , PhototherapyABSTRACT
BACKGROUND: The summarized guidelines update the 2014 recommendations for the management of AD with phototherapy and systemic therapies. METHODS: A multidisciplinary workgroup conducted a systematic review and applied the GRADE approach for assessing the certainty of the evidence and formulating and grading recommendations. RESULTS: The workgroup developed 11 recommendations on the management of AD in adults with phototherapy and systemic therapies, including biologics, oral Janus Kinase inhibitors, and other immunomodulatory medications. CONCLUSIONS: The evidence supported strong recommendations for the use of dupilumab, tralokinumab, abrocitinib, baricitinib, and upadacitinib and conditional recommendations in favor of using phototherapy, azathioprine, cyclosporine, methotrexate, and mycophenolate, and against the use of systemic corticosteroids.
Subject(s)
Dermatitis, Atopic , Adult , Humans , Cyclosporine/therapeutic use , Dermatitis, Atopic/drug therapy , Immunosuppressive Agents/therapeutic use , Methotrexate/therapeutic use , PhototherapyABSTRACT
The hepatic accumulation of excess triglycerides is a seminal event in the initiation and progression of non-alcoholic fatty liver disease (NAFLD). Hepatic steatosis occurs when the hepatic accrual of fatty acids from the plasma and de novo lipogenesis (DNL) is no longer balanced by rates of fatty acid oxidation and secretion of very low-density lipoprotein-triglycerides. Accumulating data indicate that increased rates of DNL are central to the development of hepatic steatosis in NAFLD. Whereas the main drivers in NAFLD are transcriptional, owing to both hyperinsulinemia and hyperglycaemia, the effectors of DNL are a series of well-characterised enzymes. Several have proven amenable to pharmacologic inhibition or oligonucleotide-mediated knockdown, with lead compounds showing liver fat-lowering efficacy in phase II clinical trials. In humans with NAFLD, percent reductions in liver fat have closely mirrored percent inhibition of DNL, thereby affirming the critical contributions of DNL to NAFLD pathogenesis. The safety profiles of these compounds have so far been encouraging. It is anticipated that inhibitors of DNL, when administered alone or in combination with other therapeutic agents, will become important agents in the management of human NAFLD.
Subject(s)
Non-alcoholic Fatty Liver Disease , Humans , Non-alcoholic Fatty Liver Disease/metabolism , Lipogenesis/physiology , Liver/pathology , Lipid Metabolism , Triglycerides/metabolismABSTRACT
The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 2005, along with updated information regarding product types and concentrations of use, and confirmed that these 22 methacrylate ester monomers are safe as used in nail enhancement products in the practices of use and concentration as described in this report, when skin contact is avoided.
Subject(s)
Cosmetics , Skin , Cosmetics/toxicity , Methacrylates/toxicityABSTRACT
The Expert Panel for Cosmetic Ingredient Safety reviewed updated information that has become available since their original assessment from 2001, along with updated information regarding product types, and frequency and concentrations of use, and reaffirmed their original conclusion that Peanut Glycerides is safe as a cosmetic ingredient in the practices of use and concentration as described in this report.
Subject(s)
Consumer Product Safety , Cosmetics , Arachis , Glycerides , Cosmetics/toxicityABSTRACT
The Expert Panel for Cosmetic Ingredient Safety reviewed updated information that has become available since their original assessment from 2007, along with updated information regarding product types, and frequency and concentrations of use, and reaffirmed their original conclusion that HC Yellow 5 is safe as a hair dye ingredient in the practices of use and concentration as described in this report.
Subject(s)
Cosmetics , Hair Dyes , Consumer Product Safety , Cosmetics/toxicity , Hair Dyes/toxicityABSTRACT
The Expert Panel for Cosmetic Ingredient Safety reviewed updated information that has become available since their original assessment from 1991, along with updated information regarding product types, and frequency and concentrations of use, and reaffirmed their original conclusion that Polyacrylamide is safe as a cosmetic ingredient in the practices of use and concentration as described in this report.
Subject(s)
Consumer Product Safety , Cosmetics , Acrylic Resins/toxicity , Cosmetics/toxicityABSTRACT
The Expert Panel for Cosmetic Ingredient Safety reviewed updated information that has become available since their original assessment from 1998, along with updated information regarding product types, and frequency and concentrations of use, and reaffirmed their original conclusion that Mink Oil is safe as a cosmetic ingredient in the practices of use and concentration as described in this report.
Subject(s)
Consumer Product Safety , Cosmetics , Glycerides , Cosmetics/toxicityABSTRACT
The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 2002, along with updated information regarding product types and concentrations of use, and confirmed that these 17 glyceryl diesters are safe as cosmetic ingredients in the practices of use and concentration as described in this report.
Subject(s)
Consumer Product Safety , Cosmetics , Toxicity Tests , Cosmetics/toxicityABSTRACT
The Expert Panel for Cosmetic Ingredient Safety reviewed updated information that has become available since their original assessment from 2004, along with updated information regarding product types, and frequency and concentrations of use, and reaffirmed their original conclusion that Dioscorea Villosa (Wild Yam) Root Extract is safe as a cosmetic ingredient in the practices of use and concentration as described in this report.
Subject(s)
Cosmetics , Dioscorea , Plant Extracts/toxicity , Consumer Product SafetyABSTRACT
The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in year 2000, along with updated information regarding product types and concentrations of use, and confirmed that PEG-5, -10, -16, -25, -30, and -40 Soy Sterol are safe as cosmetic ingredients in the practices of use and concentration as described in this report.