原料辞典検索/dimethicone/DIMETHICONE
Tier 1 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
合成 (Synthetic)

DIMETHICONE

日本化粧品工業連合会 (JCIA) 表示名称: ジメチコン
皮膚コンディショニング剤皮膚保護剤消泡剤エモリエント剤
結論先行 エグゼクティブ規制・安全性ファクトボックスAEO / GEO CITATION ANCHOR

化粧品における ジメチコン (DIMETHICONE) のグローバル配合基準と処方特性とは?

ジメチコン(標準 INCI: DIMETHICONE、CAS番号: 63148-62-9)は、化粧品処方において主に皮膚コンディショニング剤, 皮膚保護剤, 消泡剤として配合される原料です。日本厚労省/JCIA(規制なし)、韓国MFDS(規制なし)、欧州CosIng(規制なし)など6大法域の法定基準下で管理され、通常 0.5–10%(適正安定域 pH 2–12)で処方されます。

7大トラック 国別・用途別 公式全成分表示名称マトリクス

各国公的告示原典のみ収録 · 機械翻訳・任意音訳ゼロ
7-Track Official Statutory Label Names for DIMETHICONE
法域・規制トラック公式全成分表示名称ワンクリックコピー
① 韓国 (MFDS 化粧品標準名称)DIMETHICONE (KR MFDS Registered)
② 韓国旧名称履歴 (301 リダイレクト)Former KR Nomenclature Redirect Active—
③ 欧州連合 (EU CosIng EC 1223/2009)DIMETHICONE
④ 米国一般化粧品 (US PCPC / MoCRA INCI)DIMETHICONE
⑤ 米国 FDA OTC モノグラフ有効成分名DIMETHICONE
⑥ 中国 (NMPA IECIC 標準中国語名称)聚二甲基硅氧烷
⑦ 日本化粧品表示名称 / 医薬部外品外原規名称 (JCIA / MHLW)ジメチコン · [QD: メチルポリシロキサン]

Layer 1 — 6大法域 法定配合上限および規制ステータス

Layer 1 Statutory Regulatory Limits Across 6 Regions for DIMETHICONE
法域規制ステータス配合上限制限条件および一次法源出典
韓国 (MFDS)規制なしGMP公的化粧品原料目録収載 (GMP基準内使用)
欧州 (EU)規制なしGMP公的化粧品原料目録収載 (GMP基準内使用)
米国 (FDA)規制なしGMP公的化粧品原料目録収載 (GMP基準内使用)
中国 (NMPA)配合可能GMPIECIC Entry #3732
日本 (MHLW)規制なしGMP公的化粧品原料目録収載 (GMP基準内使用)
ASEAN (ACD)規制なしGMP公的化粧品原料目録収載 (GMP基準内使用)

Layer 2 — 毒性・安全性評価上限 (US CIR / EU SCCS / CN IECIC)

「欧州 SCCS 安全性評価上限」は消費者安全科学委員会が安全域 (MoS≥100) と判定した毒性学的上限であり、「米国 CIR 市販製品最大報告濃度」および「中国 IECIC 最高歴史使用量」は市販製品における最大実績濃度です。

Layer 2 Toxicological & Historical Safe Use Concentrations for DIMETHICONE
安全性評価基準適用範囲・用途安全濃度範囲判定結果および文献参照
中国 IECIC 最高歴史使用量leave_on≤ 85%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 03477 (2025)
中国 IECIC 最高歴史使用量rinse_off≤ 30%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 03477 (2025)
⚠️ 参考用案内 (免責事項): 本辞典の成分名・規制上限・処方ガイドは研究開発の参考用です。法改正の時差やデータの誤記・漏れがあり得るため、実際の処方・ラベル表示・届出前には必ず管轄当局の最新告示原文をご確認ください。本情報の利用により生じた問題について運営主体は法的責任を負いません。
Interactive Quartile Box-Plot (Min–Q1–Median–Q3–Max)

Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit

Emulsion / Creamn=286
Min 0.5% · Q1 1% · Median 2% · Q3 4% · Max 10%
Sunscreen / Colorn=134
Min 1% · Q1 3% · Median 5% · Q3 10% · Max 20%
Anhydrous Balm / Oiln=8
Min 0.5% · Q1 4.5% · Median 7.5% · Q3 20.1875% · Max 65%
Aqueous Serum / Ampoulen=45
Min 0.1% · Q1 1.5% · Median 3% · Q3 10% · Max 48%
Rinse-off Cleansern=5
Min 0.5% · Q1 0.5% · Median 1% · Q3 1.5% · Max 2%
Emulsion / Cream — Anti-soaping agent, silky slip modifier & breathable skin protectant
Verified Source: Dow XIAMETER PMX-200 100cSt TDS & CIR Assessment (cir_safety) · Dow 142 · Grant 84 · Evonik 60
Typical Median: 2%

Layer 3 — 剤形別通常配合濃度 (四分位数 n≥5) & 物理化学・相溶性ガイド

Layer 3 Formulation Concentration Quartiles by Product Category for DIMETHICONE
剤形グループMin – Q1 – Median – Q3 – Max (%)処方役割・作用機序Source ID
剤形群 B — 乳液・エマルジョン・クリーム0.5% · 1% · 2% · 4% · 10%Anti-soaping agent, silky slip modifier & breathable skin protectantDow XIAMETER PMX-200 100cSt TDS & CIR Assessment
剤形群 D — 日焼け止め (UV)・メイクアップ・ファンデーション1% · 3% · 5% · 10% · 20%Water-repellent sunscreen & primer sensory modifierUS FDA OTC Skin Protectant Monograph (1~30%) & CIR
剤形群 E — 無水オイル・バーム・リップケア0.5% · 4.5% · 7.5% · 20.1875% · 65%Anhydrous balm, oil & stick structural emollientGlobal Starter Formulation Library Statistical Distribution (n=8, GRANT 5 · ELEMENTIS 2 · EVONIK 1)
剤形群 A — 水성化粧水・美容液・アンプル0.1% · 1.5% · 3% · 10% · 48%Aqueous serum, toner & hydrogel matrix formulation componentGlobal Starter Formulation Library Statistical Distribution (n=45, GRANT 26 · SEPPIC 9 · EVONIK 7 · ELEMENTIS 3)
剤形群 C — 洗い流し用クレンザー・シャンプー0.5% · 0.5% · 1% · 1.5% · 2%Rinse-off cleanser & surfactant system modifierGlobal Starter Formulation Library Statistical Distribution (n=5, SEPPIC 3 · GRANT 2)
Cutaneous Permeation Science (500 Dalton Rule)MW: Macro/Complex · LogP: N/A

Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery

Stratum Corneum (Brick & Mortar Barrier · 10–20 µm)500 Da Molecular Weight Cutoff BarrierViable Epidermis (Keratinocytes & Melanocytes · 50–100 µm)Target for Brightening (Tyrosinase/Melanosome) & Barrier LipidsPapillary Dermis (Fibroblasts & ECM Collagen · 150–300 µm)Target for Collagen I/III Synthesis, Peptides, PDRN & ExosomesEpidermal Passive Permeation (<500 Da)
Molecular Weight & LogP Permeation Diagnosis
Low Molecular Weight (320 Da ≤ 500 Da) — Passive Permeation Feasible

Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.

Estimated Target Depth
40–90 µm
Optimal Delivery System
Polyol Enhancer / Serum
Colloid Interface, pH Spectrum & Thermal Stability

pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior

Soluble in silicones and light alkanes; insoluble in water and polar glycols
Optimal Formulation pH Stability Window (0–14)pH 2.0 – 12.0
0245.5791114

Outside pH 2–12, risk of hydrolysis, viscosity loss, or ionic dissociation increases.

Maximum Thermal Processing Limit (°C)≤ 95°C
25°C45°C60°C75°C85°C100°C

Thermally stable up to 95°C during standard emulsification.

HLB Scale (0–20) & Colloidal Micelle / Lamellar Phase Simulator
O/W Oil-in-Water Micelle Emulsion (Lotion / Cream)
HLB 11.5
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)O/W Droplet
Biochemical Signaling & Mechanism Pathway

Cellular & Molecular Target Mechanism Flow

1. Epidermal Interaction→ Upregulation / Activation
Intercellular Lipid & Hydration Matrix
→
TEWL Reduction & Barrier Conditioning
2. Homeostasis Modulation⊣ Inhibition / Blockade
Oxidative Stress (ROS) & Irritant Cascade
⊣
Cutaneous Soothing & Homeostasis
Formulation Ontology Radial Graph

Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)

+ CETEARYL OLIVATE+ CYCLOPENTASILOXANE+ PHENYL TRIMETHICONE+ C15-19 ALKANE✕ High-viscosity grade…DIMETHICONE
Interactive Node Guide

Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.

代表商品名参考 (商標法第90条第1項第2号 記述的表示)
XIAMETER™ PMX-200 Fluid (6cSt ~ 1000cSt)Belsil® DM

商品名は研究者がグレードを識別するための参考表記であり、各商標権は原メーカーに帰属します。

学術・毒性・処方統合モノグラフ

Tier 1 Synthesis

本原料に紐づく NIH PubMed 査読付き論文アブストラクトおよび公的毒性評価報告書のみに基づいて作成された学術要約です。

■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: DIMETHICONE | CAS No.: 63148-62-9 | EC No.: N/A - Origin: SYNTHETIC | Functions: Skin Conditioning, , , - Physicochemical Profile: Formula (C2H6OSi)n | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | PubChem CID 24759 - Official Regional Label Names: US [DIMETHICONE] · EU [DIMETHICONE] · CN [聚二甲基硅氧烷] · JP [ジメチコン] · JP Quasi-Drug [メチルポリシロキサン] ■ [2. Dermatological Mechanism of Action & Functional Role] - DIMETHICONE functions primarily as , , , in dermatological and cosmetic formulations. Classified under origin 'synthetic', it acts within the cosmetic vehicle or stratum corneum to deliver , , , performance and structural formulation stability. ■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)] - Regional Summary: KR: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 3732 (聚二甲基硅氧烷)) - No specific Annex prohibition or numeric restriction across the 6 major jurisdictions (Permitted under general GMP safety assessment). - Official Safety & Historical Use Concentration (Layer 2): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 85.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 30.0% ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [emulsion_cream] Typical range: 0.5 ~ 10.0% (Median 2.0%, Ref: Dow XIAMETER PMX-200 100cSt TDS & CIR Assessment) — Anti-soaping agent, silky slip modifier & breathable skin protectant - [sun_color] Typical range: 1.0 ~ 20.0% (Median 5.0%, Ref: US FDA OTC Skin Protectant Monograph (1~30%) & CIR) — Water-repellent sunscreen & primer sensory modifier - [anhydrous_balm] Typical range: 0.5 ~ 65.0% (Median 7.5%, Ref: Global Starter Formulation Library Statistical Distribution (n=8, GRANT 5 · ELEMENTIS 2 · EVONIK 1)) — Anhydrous balm, oil & stick structural emollient ■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)] - Addition Phase: Oil / Silicone Phase - Optimal pH Range: pH 2.0 ~ 12.0 | Max Process Temp: Max 95°C | Electrolyte Tolerance: HIGH - Incompatibility / Caution: High-viscosity grades require sufficient emulsifier structure to prevent silicone-oil phase separation - Synergy Pairings: CETEARYL OLIVATE, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE, C15-19 ALKANE | Reference Trade Names: XIAMETER™ PMX-200 Fluid (6cSt ~ 1000cSt), Belsil® DM ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 41373051 (2025, J Dent Child (Chic)): Fluoride Release, Enamel Fluoride Uptake and Dentin Tubule Occlusion From A Novel Dimethicone-Based Fluoride Varnish - PMID 39042700 (2024, PLoS Negl Trop Dis): A pilot study of dimeticone oils versus sodium carbonate treatment for tungiasis: A randomized cohort trial in Homa Bay - PMID 42019729 (2026, J Am Acad Dermatol): Plastic in dermatology: Impacts on human health, skin disease, and the contribution of personal care product use to envi

関連査読付き学術論文 (NIH PubMed) (12)

Fluoride Release, Enamel Fluoride Uptake and Dentin Tubule Occlusion From A Novel Dimethicone-Based Fluoride Varnish [PMID: 41373051 · 2025]
Greenwood RM, Omoto N, Miller S, DeCamp R, Gross SM · J Dent Child (Chic) (2025)

Purpose: To measure the fluoride release and enamel fluoride uptake from a new dimethicone-based fluoride varnish (Profisil) and Duraphat fluoride varnish, and determine if the varnishes occlude dentin tubules. Methods: The fluoride release of both varnishes was measured from specimens with a constant surface area to volume ratio in a water bath. The fluoride uptake of demineralized enamel cores treated with both varnishes was studied over 24 hours using ion-specific electrodes to determine fluoride content and atomic absorption spectroscopy to determine calcium content. Scanning electron microscopy (SEM) was used to examine the occlusion of dentin tubules and the surface of enamel after treatment with varnish. Results: Duraphat varnish released 68&#xb1;7.1 ppm of fluoride per gram of varnish after 24 hours. Profisil varnish released 65&#xb1;6.3 ppm of fluoride per gram of varnish after 24 hours. Duraphat varnish specimens had a fluoride content of 2.5&#xb1;1.8 mg F/g enamel before application of the varnish, which increased to 285&#xb1;62 mg F/g enamel after 24 hours. Profisil varnish specimens had a fluoride content of 2.4&#xb1;2.1 mg F/genamel before application of the varnish, which increased to 272&#xb1;74 mg F/g enamel after 24 hours. SEM images depicted that both varnishes occluded open dentin tubules and left mineral deposits on the surface of the enamel. Conclusions: Both varnishes released significant amounts of fluoride and significantly increased the fluoride uptake of demineralized enamel. Moreover, the new varnish induced occlusion of the tubules and induced mineral growth on the surface of the enamel.

A pilot study of dimeticone oils versus sodium carbonate treatment for tungiasis: A randomized cohort trial in Homa Bay County, Kenya [PMID: 39042700 · 2024]
Suzuki K, Kamiya Y, Smith C, Kaneko S, Okomo G, Ongaya A, Amukoye E · PLoS Negl Trop Dis (2024)

Tungiasis is a cutaneous parasitosis caused by the female flea Tunga penetrans. Two-component dimeticone (NYDA) is the only treatment for tungiasis recommended by the World Health Organization; however, this topical drug is not available in Kenya. In Western Kenya, sodium carbonate is commonly used in the treatment of tungiasis. This study evaluated the 7-day cure rates for tungiasis by comparing sodium carbonate and NYDA treatments in Homa Bay County, Kenya. This was a randomized, observer-blinded, parallel-treatment cohort trial. Twenty-three eligible children with 126 flea infections were matched and randomized. All participants received both treatments, with one treatment on each foot. We recorded all health conditions/information, including inflammation scores and adverse events. Observations were performed on days 3, 5, and 7 using a digital microscope to confirm dead or live fleas based on the viability signs. Twenty-three children aged 3-13 years were analyzed. The proportion of dead fleas on day 7 was higher after NYDA treatment than after 5% sodium carbonate treatment (87% versus 64%, respectively, P = 0.01) NYDA. Median survival was 5 days for both treatments; NYDA had significantly higher trend of flea non-viability rate than 5% sodium carbonate (P&lt;0.01). There were no significant differences in the inflammation score or pain/itchiness between the two treatments. On the last day, 14 children indicated their preference for NYDA in future treatment of tungiasis, whereas nine children preferred the 5% sodium carbonate solution. NYDA was significantly more effective than 5% sodium carbonate for tungiasis treatment. Both treatments were safe but the children preferred NYDA more. Future studies with more participants and an extended observation period are warranted to confirm our findings. The findings suggest that NYDA should be made more available in tungiasis endemic area. UMIN-CTR; UMIN 000044320.

Plastic in dermatology: Impacts on human health, skin disease, and the contribution of personal care product use to environmental pollution [PMID: 42019729 · 2026]
Anderson A, Tan E, Dunlop S · J Am Acad Dermatol (2026)

There is increasing concern within the scientific community and the general population regarding the impacts of personal care product (PCP) use on human health and the environment. This article outlines evidence regarding the health and environmental impacts associated with PCP use. Specifically, it examines the impacts of intentionally added plastic particles or "microbeads"; microplastics and nanoplastics which are shed during plastic degradation from PCP packaging during use and once discarded in the environment; and chemicals of concern, including plastic-associated chemicals and nonplastic polymers not classified as plastics used in PCPs. Recommendations to reduce the impact of PCPs on human health and the environment will be discussed.

Tailoring the Stability of W/O/W Liquid Foundations: A Comparative Study of Polyglycerol-Based W/O Emulsifiers [PMID: 41835609 · 2026]
Zhu C, Zeng L, Xie Z, et al. · ACS Omega (2026)

Water-in-oil-in-water (W/O/W) multiple emulsions are thermodynamically unstable systems characterized by high interfacial free energy and complex thermodynamic driving force promoting internal droplet coalescence or Laplace pressure-driven water migration. In color cosmetics such as liquid foundations, this intrinsic instability is further exacerbated by the incorporation of inorganic pigments (e.g., titanium dioxide (TiO 2 ) and iron oxides), which perturb the delicate interfacial equilibrium and trigger premature phase separation. Utilizing polyglyceryl-10 stearate (PG10S) as a fixed oil-in-water (O/W) emulsifier, this study systematically investigated the stability of these challenging systems by assessing four polyglycerol-based water-in-oil (W/O) emulsifiers with distinct molecular architectures: polyglyceryl-3 polydimethylsiloxyethyl dimethicone (KF-6106), polyglyceryl-6 polyricinoleate (PR-15), polyglyceryl-3 polyricinoleate (PG3PR), and polyglyceryl-2 dipolyhydroxystearate (PGPH). Through a combination of confocal laser scanning microscopy (CLSM), rheometry, differential scanning calorimetry (DSC), surface/interfacial tension analysis, and accelerated stability testing, the structure-property relationships governing the integrity of the multiple-layered structure under both intrinsic and pigment-induced stresses were elucidated. The results demonstrate that the silicone-modified emulsifier (KF-6106) exhibited superior stabilizing efficacy, achieving a high thixotropic recovery of 91.16%. This performance is attributed to its ability to form a resilient, "self-healing" interfacial film with high segmental mobility, which effectively suppresses the spontaneous merging of internal droplets and maintains a robust barrier against the destabilizing effects of pigment particles. These findings establish a mechanistic framework for optimizing emulsifier selection and provide theoretical guidance for the rational design of stable, high-performance W/O/W multiple emulsions in complex, particle-filled systems.

Skin cleansers and leave-on product interventions for preventing incontinence-associated dermatitis in adults [PMID: 40643063 · 2025]
Graham T, Beeckman D, Kottner J, et al. · Cochrane Database Syst Rev (2025)

Incontinence-associated dermatitis (IAD) is a common skin problem in adults with urinary incontinence, faecal incontinence, or both. Prevention involves skin care interventions such as skin cleansing and the application of skin protectants/barriers (leave-on products). To assess the effects of skin care cleansers, leave-on products, and procedures for preventing incontinence-associated dermatitis in adults. On 29 April 2024, we searched the Cochrane Incontinence Specialised Register - which includes searches of CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, and WHO ICTRP - and hand-searched journals and conference proceedings. We searched reference lists of included studies to identify additional studies. We selected randomised controlled trials (RCTs) and quasi-RCTs conducted in any healthcare setting and involving participants aged over 18 years without IAD at baseline. We included trials comparing the effectiveness of skin cleansing interventions and leave-on products or combinations of interventions/leave-on products. Three review authors independently screened the titles, abstracts, and full-text articles. Four review authors independently extracted data and assessed risk of bias. Data from studies not published in English were translated and extracted by volunteers from Cochrane Engage and the review authors' networks. Primary outcomes were: number of participants with IAD and adverse effects related to the intervention (pain, skin rash, itching, and other serious adverse effects). Secondary outcomes were: number of participants satisfied with skin care products or procedures, adherence to the protocol throughout the intervention, and quality of life (condition-specific or generic). We used GRADE to assess the certainty of the evidence. We included 15 trials with 1020 participants in a qualitative synthesis (41 participants from nursing homes; 65 from both care homes and hospital, and 914 from hospital settings). Participants had urinary incontinence, faecal incontinence, or both. Thirteen trials had small sample sizes and two trials had 180 and 174 participants. Six trials assessed outcomes in the short term (&#x2264; 7 days), four in the medium term (8 days-1 month), and one in the long term (&gt; 1 month-3 months). In the remaining studies, the timing of assessment was unclear. The overall risk of bias in the included studies was high. Substantial heterogeneity (in study populations, skin care products, skin care procedures, outcomes, and measurement tools) precluded meta-analysis. Three trials compared skin cleansing interventions, and five trials compared leave-on products or a combination of leave-on products. Seven trials compared a combination of skin cleansers and leave-on products. Number of participants with incontinence-associated dermatitis Three trials compared a skin cleanser with soap and water. One provided evidence that using a foam cleanser might be more effective than soap and water for preventing IAD (RR 0.35, 95% CI 0.14 to 0.85; 65 participants; very low-certainty evidence), while another found little or no difference in effectiveness between a disposable washcloth containing 3% dimethicone and soap and water (RR 0.14, 95% CI 0.01 to 2.28; 12 participants; very low-certainty evidence). The third trial reported lower erythema scores with a no-rinse skin cleanser compared with soap and water, but we were unable to analyse these data. In trials evaluating combinations of skin cleansers and leave-on products versus skin cleansing alone, one suggested the combined treatment may be more effective for preventing IAD (RR 0.03, 95% CI 0.00 to 0.53; 180 participants; very low certainty of evidence), and the other showed little to no difference between interventions (RR 0.71, 95% CI 0.14 to 3.68; 31 participants; very low-certainty evidence). Two studies showed little to no difference between a combination of leave-on products versus a single product (RR 0.85, 95% CI 0.

Cleansing Mechanisms and Efficacy on Artificial Skin [PMID: 40333845 · 2025]
Slavova T, Stanimirova R, Marinova K, et al. · Molecules (2025)

A systematic study on the mechanisms of cleansing artificial skin by solutions of widely used in personal care surfactants disodium laureth sulfosuccinate (DSLSS), sodium laureth sulfate (SLES), sodium dodecyl sulfate (SDS), dodecyl trimethyl ammonium bromide (DTAB), and coco glucoside (CG), is presented. The systematic characterization of soil removal from artificial skin revealed two primary cleansing mechanisms: emulsification and roll-up. Emulsification occurs in systems with very low interfacial tension, such as sebum in SLES solutions, while dimethicone soil was only removed by roll-up. The roll-up effectiveness depends on the surfactant's interfacial activity and its adsorption on the soiled surface. Thus, the strong adsorption of DTAB on the skin leads to dimethicone roll-up at a relatively high interfacial tension of 11 mN/m. The anionic and nonionic surfactants adsorbed less at the artificial skin surface, and the oil/water interfacial tension value lowering below 5 mN/m is necessary for the roll-up to occur. Nonionic CG removed dimethicone at a lower concentration than ionic surfactants. Combining CG with ionic surfactants improved cleaning at lower total concentrations. Surfactant mixtures are used to formulate simple cleansing formulations, whose performance is also investigated by the developed in vitro approach. The results obtained allow for a good rating of the formulations, which correlates well with the performance of the surfactant mixtures and their interfacial activity.

The Role of Moisturizer Containing Anti-inflammatory on Skin Hydration in Mild-Moderate Atopic Dermatitis Patients [PMID: 39741562 · 2024]
Prakoeswa CRS, Damayanti, Anggraeni S, et al. · Dermatol Res Pract (2024)

Atopic dermatitis (AD) is a chronic, inflammatory skin condition characterized by eczema lesions and dry, itchy skin. Recent guidelines for the management of AD emphasize the importance of using moisturizers in the management of AD. This study is a double-blind clinical trial to determine the effectiveness of moisturizers containing anti-inflammatory ingredients compared with moisturizers without anti-inflammatory ingredients for skin hydration in mild to moderate adult AD patients for 14&#x2009;days at the Dermatology and Venereology Outpatient Clinic at Dr. Soetomo General Academic Hospital. There was a significant difference ( p &lt; 0.05) at the baseline and day 14 skin hydration values in the experiment group with anti-inflammatory ingredients (35.97&#x2009;&#xb1;&#x2009;6.04-66.06&#x2009;&#xb1;&#x2009;15.84) and the control group without anti-inflammatory ingredients (40.74&#x2009;&#xb1;&#x2009;10.94-56.12&#x2009;&#xb1;&#x2009;8.34). After comparison, there was a significant difference ( p &lt; 0.05) in the skin hydration value between the experiment group and the control group on the 14th day. There was also a significant difference in the improvement of skin hydration outcomes between both groups ( p &lt; 0.05). The severity of the disease using Scoring Atopic Dermatitis (SCORAD) showed a significant difference ( p &lt; 0.05) between the experiment group and the control group after 2&#x2009;weeks of intervention. The addition of anti-inflammatory ingredients in the moisturizer, namely, shea butter, bacterial lysate, allantoin, bisabolol, Phragmites kharka extract, Poria cocos , and Mirabilis jalapa in a moisturizer containing occlusive (dimethicone), humectants (glycerin, saccharide, butylene glycol, and hyaluronic acid), and emollient (shea butter and squalane) was shown to be significantly better in improving skin hydration in patients with mild to moderate AD.

Structural Similarity-Induced Inter-Component Interaction in Silicone Polymer-Based Composite Sunscreen Film for Enhanced UV Protection [PMID: 39684059 · 2024]
Chen Y, Xu H, Liu Y, et al. · Polymers (Basel) (2024)

Film-forming agents are key ingredients in achieving long-lasting and effective sun protection by sunscreens. However, studies on the synergistic effects of film-forming agents with different properties as well as the interaction between film-forming agents and powders are scarce, restricting the development of sunscreens with strong ultraviolet (UV)-shielding effects. Herein, we innovatively adopt polysiloxane-15 as the soft film, trimethylsiloxysilicate as the hard film, and vinyl dimethicone/methicone silsesquioxane crosspolymer as the functional powder to construct a co-assembled sunscreen film, and we investigate the property-enhancing effects of the sunscreen film as well as the interaction between the silicone polymer-based film-forming agents and functional powder therein. The results show that structural similarity is essential to generating film-forming agent-powder interactions, which primarily enhance the Si-O bond binding energy, thereby enhancing the lasting protection effect of sunscreens. In addition, the inter-component interaction of the co-assembled sunscreen film inhibits the agglomeration of sunscreen paste to facilitate the formation of a homogeneous film, endowing the sunscreen with excellent UV protection abilities, with the sun protection factor (SPF) and protection factor of UVA (PFA) values increased by 61.58 and 43.84%, respectively. This work offers novel insights into the optimization of film-forming agent properties and the development of durable and efficient sunscreens.

Characteristics of Diaper Dermatitis in Patients Aged 0-24 Months After Congenital Heart Disease and the Effects of a Diaper Dermatitis Care Bundle: A Comparison of 2 Groups [PMID: 39588819 · 2024]
Chin PJ, Liao LN, Huang LC · J Wound Ostomy Continence Nurs (2024)

The purpose of this study was to examine characteristics of diaper dermatitis (DD) in critically ill patients aged 0 to 24&#xa0;months following surgery for congenital heart disease (CHD), the effects of a diaper dermatitis care bundle (DDCB), and factors associated with the development of DD in this population. Nonrandomized comparison cohort study with a historical comparison group. Convenience sampling was used to identify children aged 0 to 24&#xa0;months undergoing CHD and cared for in a pediatric intensive care unit in central Taiwan (Taichung). The sample comprised 54 participants; 24 were in the historical comparison group and 30 received the DDCB. The rate of DD from the historical comparison group was compared to that in an intervention group managed with a bundle of interventions used to prevent and manage DD, which includes the routine use of a topical skin protectant. The participants in the historical comparison group received usual care to prevent and manage DD including routine cleansing with a moistened, disposable cloth every 3&#xa0;hours and following defecation or urination. The DDCB comprised diaper changes at least every 3&#xa0;hours and as needed after soiling, along with the routine application of a dimethicone and sodium hyaluronate-based skin protectant before diaper changes. Both groups were evaluated for use of an antifungal cream when candidiasis was present. Participants managed with the DDCB have a significantly lower rate of DD than the historical comparison group who received routine care (41.65% vs 6.67%, P =&#xa0;.002). Univariate logistic regression showed an odds ratio of 0.10 (95% confidence interval of 0.019-0.520, P =&#xa0;.006), suggesting that the DDCB acted as a protective factor against the development of DD. Multivariate analysis of the historical comparison group indicated that non-cyanotic heart disease was associated with a lower likelihood of postoperative DD compared to those with cyanotic heart disease (odds ratio&#xa0;=&#xa0;0.01, 95% confidence interval of 0.000-0.946, P =&#xa0;.047). Managing critically ill patients with a DDCB recovering from cardiac surgery significantly decreased the incidence of DD. We recommend routine use of this type of care bundle for preventing DD in this vulnerable population in all children with CHD, with particular attention being paid to this with cyanotic CHD.

A New Prescription Emollient Device (PED) For Psoriasis of Sensitive Areas and Folds: A Randomized Prospective Open Trial [PMID: 39564575 · 2024]
Dall'Oglio F, Verzì AE, Guglielmi G, et al. · Psoriasis (Auckl) (2024)

Psoriasis affecting sensitive areas and folds represents a therapeutic challenging as the skin in these areas may be more prone to local pharmacological side effects. The aim of this prospective, randomized, open-label study was to evaluate the efficacy and tolerability of a new prescription emollient device (PED) as a cream containing primarily furfuryl palmitate (antioxidant, anti-inflammatory, soothing), tocopherol (antioxidant), and dimethicone (occlusive) for the treatment of psoriasis localized to difficult-to-treat areas. Thirty patients (14M/16F) with mild-to-moderate psoriasis of sensitive areas such as face, vulva, scrotum, pubic area, neck (15 cases), and of folds including axillary fossa, intergluteal cleft, submammary/inguinal folds, and umbilicus (15 cases) were consecutively enrolled and instructed to apply the cream twice daily for 8&#xa0;weeks. Efficacy was assessed at baseline, at 4 and 8&#xa0;weeks by measuring the degree of erythema, scaling, infiltration and pruritus using clinical, instrumental and subject-completed Visual Analog Scale (VAS) assessments. At the end of the study, the Investigator Global Assessment (IGA) of efficacy was performed. Statistically significant reductions in erythema, scaling, infiltration, and itching scores were observed at 8&#xa0;weeks compared to baseline. In addition, IGA efficacy score was clear in 7 cases and almost clear in 4 cases for psoriasis of sensitive areas and clear in 5 cases and almost clear in 4 cases for psoriasis of folds. No relevant side effects were observed in any of the groups. Our results suggest that the tested PED containing antioxidant, anti-inflammatory, soothing and occlusive agents may represent a valid therapeutic option for mild-to-moderate psoriasis of sensitive areas and folds in monotherapy or in combination with pharmacological agents if necessary.

Impact of Different Packaging Configurations on A Topical Cream Product [PMID: 39349693 · 2024]
Mohammed YH, Namjoshi SN, Telaprolu KC, et al. · Pharm Res (2024)

The objective of this study was to investigate whether different dispensing processes can alter the physicochemical and structural (Q3) attributes of a topical cream product, and potentially alter its performance. Acyclovir cream, 5% (Zovirax&#xae;) is sold in the UK and other countries in a tube and a pump packaging configurations. The structural attributes of the cream dispensed from each packaging configuration were analyzed by optical microscopy, confocal Raman microscopy and cryo-scanning electron microscopy. Rheological behavior of the products was also evaluated. Product performance (rate and extent of skin delivery) was assessed by in vitro permeation tests (IVPT) using heat-separated human epidermis mounted in static vertical (Franz-type) diffusion cells. Differences in Q3 attributes and IVPT profiles were observed with creams dispensed from the two packaging configurations, even though the product inside each packaging appeared to be the same in Q3 attributes. Visible globules were recognized in the sample dispensed from the pump, identified as dimethicone globules by confocal Raman microscopy. Differences in rheological behaviour could be attributed to these globules as products not dispensed through the pump, demonstrated a similar rheological behaviour. Further, IVPT confirmed a reduced rate and extent to delivery across human epidermis from the product dispensed through a pump. Different methods of dispensing topical semisolid products can result in metamorphosis and Q3 changes that may have the potential to alter the bioavailability of an active ingredient. These findings have potential implications for product developers and regulators, related to the manufacturing and comparative testing of reference standard and prospective generic products dispensed from different packaging configurations.

Safety Assessment of Vinylpyrrolidone Polymers as Used in Cosmetics [PMID: 39045851 · 2024]
Johnson W Jr, Bergfeld WF, Belsito DV, et al. · Int J Toxicol (2024)

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 30 vinylpyrrolidone polymers as used in cosmetic products; most of these ingredients have the reported cosmetic function of film former in common. The Panel reviewed data relevant to the safety of these ingredients, and determined that 27 vinylpyrrolidone polymers are safe in cosmetics in the present practices of use and concentration described in the safety assessment. The Panel also concluded that the available data are insufficient to make a determination that 3 vinylpyrrolidone polymers (all urethanes) are safe under the intended conditions of use in cosmetic formulations.

よくある質問 (FAQ)

Q1. ジメチコン (DIMETHICONE) の各国公式全成分表示名称(7トラック)はどのように異なりますか?
日本化粧品工業連合会(JCIA)表示名称は 'ジメチコン'、米国PCPC・欧州CosIng INCIは 'DIMETHICONE'、中国NMPA IECIC標準中国語名は '聚二甲基硅氧烷' です。
Q2. ジメチコン (DIMETHICONE) のグローバル6大法域における法定配合基準 (Layer 1) は?
6大法域規制ステータス — 日本(JP): none、韓国(KR): none、欧州(EU): none、米国(US): none、中国(CN): allowed、ASEAN: none。
Q3. 処方設計における ジメチコン (DIMETHICONE) の通常配合濃度 (Layer 3) と適正 pH は?
主要剤形 (emulsion_cream) において通常 0.5〜10%(中央値 2%)で配合され、適正pH範囲は 2〜12 です。
Q4. ジメチコン (DIMETHICONE) の配合禁忌 (Incompatibilities) と推奨シナジー成分は?
推奨シナジーペアは CETEARYL OLIVATE, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE, C15-19 ALKANE、配合上の注意点は High-viscosity grades require sufficient emulsifier structure to prevent silicone-oil phase separation です。