原料词典检索/zinc-pca/ZINC PCA
Tier 1 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
化学合成 (Synthetic)

ZINC PCA

中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名: PCA 锌 (序号 #429)
保湿剂皮肤调理剂
核心法规与安全结论 (Executive Fact Box)AEO / GEO CITATION ANCHOR

化妆品中 PCA 锌 (ZINC PCA) 的全球法规限值与配方应用标准是什么?

PCA 锌(标准 INCI: ZINC PCA,CAS 号: 68107-75-5)是化妆品配方中主要用作保湿剂, 皮肤调理剂的核心成分。受中国 NMPA(已使用/准用)、韩国 MFDS(限用)及欧盟 CosIng(限用)等 6 大法域法定标准监管,常规建议添加量为 0.1–1%(最佳稳定窗口 pH 4.5–6.5)。

全球 7 轨官方全成分标签名称对照表

严格采用各国政府官方目录原名 · 严禁机器翻译
7-Track Official Statutory Label Names for ZINC PCA
法域与监管轨道官方公告全成分标准名称一键复制
① 韩国 (MFDS 化妆品标准名称)ZINC PCA (KR MFDS Registered)
② 韩国旧名称历史 (301 重定向)——
③ 欧盟 (EU CosIng EC 1223/2009)ZINC PCA
④ 美国普通化妆品 (US PCPC / MoCRA INCI)ZINC PCA
⑤ 美国 OTC 防晒/祛痘专论活性物名称 (FDA OTC)— (非美国 OTC 专论活性成分 / 普通化妆品原料)—
⑥ 中国 (NMPA《已使用化妆品原料目录 IECIC》标准中文名)PCA 锌
⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW)ZINC PCA (标准 INCI 参照)

Layer 1 — 全球 6 大法域法定限值与监管状态

Layer 1 Statutory Regulatory Limits Across 6 Regions for ZINC PCA
法域监管状态法定限值适用条件与法定依据来源
韩国 (MFDS)限用GMP已列入官方化妆品原料目录 (按 GMP 规范使用)
欧盟 (EU)限用GMP已列入官方化妆品原料目录 (按 GMP 规范使用)
美国 (FDA)未列管GMP已列入官方化妆品原料目录 (按 GMP 规范使用)
中国 (NMPA)已使用/准用GMPIECIC Entry #429
日本 (MHLW)未列管GMP已列入官方化妆品原料目录 (按 GMP 规范使用)
东盟 (ACD)未列管GMP已列入官方化妆品原料目录 (按 GMP 规范使用)

Layer 2 — 毒理评估与历史最高使用量 (CN IECIC / US CIR / EU SCCS)

“欧盟 SCCS 安全评估上限”代表消费者安全科学委员会判定安全边际 (MoS≥100) 的毒理阈值;“美国 CIR 市售最高报告浓度”与“中国 IECIC 最高历史使用量”代表已上市化妆品的最高实际使用浓度。

Layer 2 Toxicological & Historical Safe Use Concentrations for ZINC PCA
安全评估依据适用范围与剂型评估浓度范围评估结论与文献档案
中国 IECIC 最高历史使用量leave_on≤ 2%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 00712 (2025)
中国 IECIC 最高历史使用量rinse_off≤ 1%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 00712 (2025)
⚠️ 仅供参考 (免责声明): 本词典中的原料名称、法规限值与配比指南仅供研发参考。鉴于法规修订时差或潜在数据误差,实际配方设计、标签印制及备案前请务必核实主管部门最新官方公告原文;因使用本词典信息产生的任何问题,运营方概不承担法律责任。
Interactive Quartile Box-Plot (Min–Q1–Median–Q3–Max)

Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit

Aqueous Serum / Ampoulen=44
Min 0.1% · Q1 0.2% · Median 0.5% · Q3 1% · Max 1%
Aqueous Serum / Ampoule — 5α-reductase sebum inhibitor, anti-acne antimicrobial & physiological humectant
Verified Source: Solabia Zincidone / Ajinomoto Ajidew ZN-100 TDS & CIR Assessment (cir_safety) · Solabia · Ajinomoto · US/ASEAN Derm
Typical Median: 0.5%

Layer 3 — 剂型常规配比指南与理化配伍性

Layer 3 Formulation Concentration Quartiles by Product Category for ZINC PCA
剂型分类Min – Q1 – Median – Q3 – Max (%)配方作用与机理Source ID
剂型组 A — 水剂爽肤水 / 精华液 / 安瓶0.1% · 0.2% · 0.5% · 1% · 1%5α-reductase sebum inhibitor, anti-acne antimicrobial & physiological humectantSolabia Zincidone / Ajinomoto Ajidew ZN-100 TDS & CIR Assessment
Cutaneous Permeation Science (500 Dalton Rule)MW: 321.58 Da · 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 (321.58 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

Freely soluble in water
Optimal Formulation pH Stability Window (0–14)pH 4.5 – 6.5
0245.5791114

Outside pH 4.5–6.5, risk of hydrolysis, viscosity loss, or ionic dissociation increases.

Maximum Thermal Processing Limit (°C)≤ 70°C
25°C45°C60°C75°C85°C100°C

Thermally stable up to 70°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)

+ NIACINAMIDE+ SUCCINIC ACID+ SALICYLIC ACID+ XANTHAN GUM+ POLYACRYLATE CROSS…✕ Divalent Zn2+ ion im…✕ Precipitates as inso…ZINC PCA
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.

代表性商品名参考 (商标法第90条第1款第2项说明性标示)
Zincidone® (Solabia)Ajidew® ZN-100

商品名仅供配方师识别原料规格参考,商标权归各原厂商所有。

学术与毒理综合摘要

Tier 1 Synthesis

本综述严格基于与该原料关联的 NIH PubMed 同行评审文献摘要及官方毒理学评估档案编写。

■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: ZINC PCA | CAS No.: 68107-75-5 | EC No.: 268-475-9 - Origin: SYNTHETIC | Functions: , - Physicochemical Profile: Formula C10H12N2O6Zn | MW 321.58 g/mol | / | Ionic Nature: cationic | PubChem CID 115221 - Official Regional Label Names: US [ZINC PCA] · EU [ZINC PCA] · CN [PCA 锌] · JP [-] · JP Quasi-Drug [-] ■ [2. Dermatological Mechanism of Action & Functional Role] - ZINC PCA 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: RESTRICTED | EU: RESTRICTED | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 429 (PCA 锌)) - [KR / COMPOSITION / limited] (Max 1%): - [EU / COMPOSITION / limited] (Max 1%): - Official Safety & Historical Use Concentration (Layer 2): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 2.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 1.0% ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [aqueous_serum] Typical range: 0.1 ~ 1.0% (Median 0.5%, Ref: Solabia Zincidone / Ajinomoto Ajidew ZN-100 TDS & CIR Assessment) — 5α-reductase sebum inhibitor, anti-acne antimicrobial & physiological humectant ■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)] - Addition Phase: Water Phase (< 60°C) - Optimal pH Range: pH 4.5 ~ 6.5 | Max Process Temp: Max 70°C | Electrolyte Tolerance: NONE - Incompatibility / Caution: Divalent Zn2+ ion immediately collapses standard Carbomer gels; use Xanthan Gum, Sclerotium Gum, HEC, or SEPIMAX ZEN - Incompatibility / Caution: Precipitates as insoluble Zinc Hydroxide above pH 7.0; maintain pH 4.8~6.0 - Synergy Pairings: NIACINAMIDE, SUCCINIC ACID, SALICYLIC ACID, XANTHAN GUM, POLYACRYLATE CROSSPOLYMER-6 | Reference Trade Names: Zincidone® (Solabia), Ajidew® ZN-100 ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 39778065 (2025, J Cosmet Dermatol): A Cohort Clinical Study on the Efficacy of Topical Salicylic Acid/Piroctone Olamine Dandruff Pre-Gel and Cleanser in Imp - PMID 35330623 (2022, Clin Cosmet Investig Dermatol): Facial Seborrheic Dermatitis in HIV-Seropositive Patients: Evaluation of the Efficacy and Safety of a Non-Steroidal Crea - PMID 33934474 (2021, J Cosmet Dermatol): Treatment of cradle cap in infants with a new cosmetic non-steroidal gel cream: Clinical, laboratory, and instrumental e

关联同行评审文献 (NIH PubMed) (14)

A Cohort Clinical Study on the Efficacy of Topical Salicylic Acid/Piroctone Olamine Dandruff Pre-Gel and Cleanser in Improving Symptoms of Moderate to Severe Seborrheic Dermatitis of the Scalp [PMID: 39778065 · 2025]
Ge L, Liu Z, Xu S, Li C, Jin M, Luo Y, Kong Y, Meng J, Zheng G, Gao J, Wang P, Bai W, Na H, Zhou X, Jin Z, Pi L · J Cosmet Dermatol (2025)

Scalp seborrheic dermatitis (SD) is a chronic, recurrent inflammatory skin condition associated with scalp sebum secretion and dysbiosis. The aim of this study is to evaluate the efficacy and safety of a topical salicylic acid/piroctone olamine/zinc salt of L-pyrrolidone carboxylate (Zinc PCA) scalp pre-application gel in combination with a salicylic acid/piroctone olamine/antimicrobial peptide cleansing lotion for the treatment of moderate to severe scalp SD. In this prospective cohort study, 20 patients with moderate to severe scalp SD were treated with a combination of the scalp pre-application gel and cleansing lotion for 4&#x2009;weeks (one tube of the pre-application gel per week and the cleansing lotion used every 1-3&#x2009;days depending on the frequency of hair washing). This was followed by maintenance treatment with the cleansing lotion for 12&#x2009;weeks. Efficacy was assessed through clinical and trichoscopic examinations, measuring the severity of dandruff, itching, erythema, and greasiness using a 4-point scale. This cohort study included a total of 20 patients with moderate to severe scalp SD. By the 4th week, the average dandruff score had significantly decreased from a baseline of 2.45 to 1.10 (p&#x2009;&lt;&#x2009;0.01). The average itchiness score reduced from 2.35 to 1.10 (p&#x2009;&lt;&#x2009;0.01), the erythema score dropped from 1.55 to 1.10 (p&#x2009;&lt;&#x2009;0.05), and the greasiness score decreased from 2.60 to 1.40 (p&#x2009;&lt;&#x2009;0.01). After 16&#x2009;weeks, 12 patients with severe SD improved to mild SD, and six patients with moderate SD also improved to mild. During the treatment, two patients experienced a recurrence of dandruff, which subsequently resolved. The overall clinical improvement was 80%. Our study results indicate that the combination treatment of the scalp pre-application gel and cleansing lotion is highly effective and safe for treating SD. The subsequent use of the cleansing lotion effectively maintains the benefits of the combined treatment. Trichoscopic examination provides accurate and reliable quantifiable data, aiding in the monitoring of treatment progress.

Facial Seborrheic Dermatitis in HIV-Seropositive Patients: Evaluation of the Efficacy and Safety of a Non-Steroidal Cream Containing Piroctone Olamine, Biosaccharide Gum-2 and Stearyl Glycyrrhetinate - A Case Series [PMID: 35330623 · 2022]
Cort&#xe9;s-Correa C, Piquero-Casals J, Chaparro-Reyes D, Garr&#xe9; Contreras A, Granger C, Pe&#xf1;aranda-Contreras E · Clin Cosmet Investig Dermatol (2022)

Facial seborrheic dermatitis is common in HIV-positive patients, and the presence of facial lesions can affect quality of life. The management and control of lesions can be frustrating for both physicians and patients. In this pilot clinical study, we clinically evaluated the effectiveness of a topical non-steroidal cream in treating mild to moderate facial seborrheic dermatitis in 20 HIV-positive patients. The patients applied a twice-a-day topical cream containing zinc PCA, piroctone olamine, hydroxyphenyl propamidobenzoic acid, biosaccharide gum-2, and stearyl glycyrrhetinate for 12 weeks with no topical or oral antifungal or corticosteroid treatment. Signs and symptoms and tolerance were assessed before, during, and at the end of treatment. All of the patients showed clinical improvement after 4 and 12 weeks of treatment. None of the patients had no response to treatment, and no adverse effects were reported. No rescue therapy with corticosteroids was needed. The patients reported a very noticeable improvement in their skin which contributed to high compliance with the protocol requirement.

Treatment of cradle cap in infants with a new cosmetic non-steroidal gel cream: Clinical, laboratory, and instrumental evaluation [PMID: 33934474 · 2021]
Micali G, Pulvirenti N, Dall'Oglio F, Tedeschi A, Quattrocchi E, Lacarrubba F · J Cosmet Dermatol (2021)

Cradle cap is a benign and self-limiting variant of seborrheic dermatitis (SD) that can be distressing for parents. To assess by clinical/laboratory/instrumental evaluation the efficacy/tolerability of a gel cream containing piroctone olamine (antifungal), biosaccharide gum-2 (antifungal), stearyl glycyrrhetinate (anti-inflammatory), and zinc l-pyrrolidone carboxylate (zinc-PCA) (antiseborrheic) in the treatment of mild/ moderate cradle cap. In this prospective, open-label trial, 10 infants, with mild/moderate cradle cap enrolled at the Dermatology University Clinic of Catania (Italy) used the tested gel cream twice daily for 30&#xa0;days. Degree of erythema was evaluated clinically by a 5-point severity scale (from 0=no erythema to 4=severe erythema), at baseline, at 15 and 30&#xa0;days. Desquamation was rated by dermoscopy evaluation using a 5-point scale (from 0=no desquamation to 4=severe/many large adherent white flakes), at all time points. An Investigator Global Assessment (IGA) using a 6-point scale (from -1=worsening to 4=complete response/clear) was also performed at 30&#xa0;days. Five subjects, randomly selected, underwent double microbiological evaluation for bacteria and yeasts by cultures of cotton swabs at baseline and at 30&#xa0;days. Tolerability/acceptability was evaluated on a 4-point scale (from 0=very poor to 3=excellent) at 15 and 30&#xa0;days. Data were processed using SAS version 9. At baseline, a significant colony-forming unit (CFU) count for Malassezia furfur and Staphylococcus aureus was detected in 4 out of 5 selected patients. After 15 and 30&#xa0;days, a statically significant reduction from baseline in erythema and desquamation severity was observed, along with a reduction in CFU count for Malassezia furfur and Staphylococcus aureus from baseline. No signs of local side effects were documented. Our results indicate that the tested gel cream may represent a valid option to treat mild-to-moderate forms of cradle cap and support its antifungal and antibacterial properties.

Non-Steroidal Topical Therapy for Facial Seborrheic Dermatitis [PMID: 32574015 · 2020]
Piquero-Casals J, La Rotta-Higuera E, Francisco Mir-Bonaf&#xe9; J, Rozas-Mu&#xf1;oz E, Granger C · J Drugs Dermatol (2020)

Seborrheic dermatitis (SD) is a chronic, recurrent, inflammatory skin disorder occurring in areas rich in sebaceous glands. It manifests clinically as erythematous macules or plaques with varying levels of scaling and associated pruritus. Although the pathogenesis of SD has yet to be fully understood, Malassezia yeasts, hormones, sebum levels, and immune response are known to play important roles. Additional factors including drugs, winter temperatures, and stress may exacerbate SD. Current available treatments include antifungal agents, topical low-potency steroids, and calcineurin inhibitors. We aimed to evaluate the effectiveness of a topical non-steroidal cream in treating facial seborrheic dermatitis (FSD). We performed a case series of 11 patients with mild or moderate FSD and a history of several previous treatments without improvement. The patients were treated for 8 weeks with a topical non-steroidal facial cream (NSFC) containing zinc PCA, piroctone olamine, hydroxyphenyl propamidobenzoic acid, biosaccharide gum-2, and stearyl glycyrrhetinate. Signs and symptoms and tolerance were assessed before, during, and at the end of treatment. All of the patients had improved symptoms of FSD (desquamation, pruritus, erythema, and stinging sensation); 81.8% showed an excellent response and 18.1% showed a good response. None of the patients had adverse effects. J Drugs Dermatol. 2020;19(6): doi:10.36849/JDD.2020.5121.

Exploring Anti-Fungal, Anti-Microbial and Anti-Inflammatory Properties of a Topical Non-Steroidal Barrier Cream in Face and Chest Seborrheic Dermatitis [PMID: 31705438 · 2020]
Balato A, Caiazzo G, Di Caprio R, Scala E, Fabbrocini G, Granger C · Dermatol Ther (Heidelb) (2020)

The pathogenesis of seborrheic dermatitis (SD) is multifactorial and traditional treatments may not target all aspects of it. The aim of this study was to evaluate short-term anti-fungal, anti-microbial, anti-inflammatory and anti-pruritus properties of a novel non-steroidal cream (NSC) containing piroctone olamine, zinc salt of L-pyrrolidone carboxylate (PCA), hydroxyphenyl propamidobenzoic acid, biosaccharide gum-2 and stearyl glycyrrhetinate in patients with face and chest SD. Twelve male subjects affected by SD, presenting face and chest manifestations, were enrolled. Patients were instructed to apply NSC twice a day, performing regular visits at baseline (W0), after 7 (W1) and 14 (W2) days of treatment. A limitation of the study was that no control group treated with the vehicle without active ingredients was enrolled. To evaluate the efficacy of the NSC, investigator's assessments were represented by scoring index (SI) and investigator's global assessment score (IGA). In order to assess NSC anti-fungal and anti-microbial effects, skin scale scrapings were collected and used for Malassezia furfur (MF) and Staphylococcus epidermidis (SE) cultures. In parallel, in order to assess NSC anti-inflammatory effects, gene expression of IL-1&#x3b1;, IL-1&#x3b2;, IL-6, IL-8, and TNF-&#x3b1; was assessed. In addition, anti-pruritus effects were also evaluated through gene expression of cathepsin S and L-histidine decarboxylase. SI mean scores significantly decreased at W1 and, to a greater extent, at W2 compared with W0. The IGA score registered an important improvement efficacy both for face and chest, from W1 to W2. MF and SE growth was already inhibited at W1, with a more pronounced decrease at W2. Gene expression of all analyzed mediators was significantly reduced at W1 compared to W0. In conclusion, our assessment is that NSC is an effective and well tolerated treatment option for SD with anti-fungal, anti-microbial and anti-inflammatory properties. ISRCTN registry, ISRCTN77871064 (retrospectively registered October 17, 2019). EudraCT number, 2019-003813-32. ISDIN.

Clinical and instrumental evaluation of a new topical non-corticosteroid antifungal/anti-inflammatory/antiseborrheic combination cream for the treatment of mild-to-moderate facial seborrheic dermatitis [PMID: 30774406 · 2019]
Dall'Oglio F, Lacarrubba F, Luca M, Boscaglia S, Granger C, Micali G · Clin Cosmet Investig Dermatol (2019)

Topical agents play a key role in the management of facial seborrheic dermatitis (SD) by reducing inflammation and scale production. The aim of this open-label trial was to assess the efficacy and tolerability of a new non-corticosteroid, antifungal/anti-inflammatory/antiseborrheic cream containing piroctone olamine, stearyl glycyrrhetinate, and zinc PCA in the treatment of facial SD using clinical and instrumental evaluation. Twenty adult subjects affected by mild-to-moderate inflamed facial SD were enrolled and instructed to apply the study cream twice daily for 60 days. Efficacy was evaluated at baseline, and at days 15, 30, and 60 by measuring the grade of desquamation, erythema, and pruritus using clinical evaluation, erythema-directed digital photography, colorimetry, and subject-completed Visual Analog Scale. Additionally, an Investigator Global Assessment (IGA) was assessed using a 5-point scale: excellent response (&gt;80% improvement); good response (50%-80% improvement); mild response (&lt;50% improvement); no response (no change); worsening. After 15 days, a statistically significant decrease from baseline was found in desquamation, erythema, colorimetric scores, and pruritus. At day 60, a significant further improvement for all evaluated parameters was recorded. Moreover, the IGA improved in 90% of patients, with an excellent response in 53% of cases. A good correlation was found between clinical and instrumental evaluations. Our results indicate that the study facial cream represents an option to consider when dealing with mild-to-moderate SD, being effective, well-tolerated, and free of significant side effects, as confirmed by clinical and instrumental evaluation.

Zinc l-pyrrolidone carboxylate inhibits the UVA-induced production of matrix metalloproteinase-1 by in vitro cultured skin fibroblasts, whereas it enhances their collagen synthesis [PMID: 21834944 · 2012]
Takino Y, Okura F, Kitazawa M, Iwasaki K, Tagami H · Int J Cosmet Sci (2012)

Reduced collagen matrix in the dermis constitutes one of the characteristic features of chronologically aged skin, which is further enhanced on the sun-exposed portions of the body by chronic ultraviolet light (UV) irradiation, inducing the unique changes associated with skin photoageing. The zinc salt of l-pyrrolidone carboxylate (Zinc PCA) has long been used as a cosmetic ingredient, because of its astringent and anti-microbial properties. In the present study, by employing cultured normal human dermal fibroblasts, we found that Zinc PCA suppressed UVA-induced activation of activator protein-1 (AP-1) and reduced matrix metalloproteinase-1 production in these cells, which is thought to be involved in collagen degradation in photoaged skin. Moreover, Zinc PCA treatment of the cells increased the expression of an ascorbic acid transporter mRNA, SVCT2, but not SVCT1, resulting in the enhanced production of type I collagen. Based on these in vitro findings, we consider Zinc PCA to be a promising candidate for an anti-skin ageing agent.

Efficacy and Tolerability of Topical Nicotinamide Plus Antibacterial Adhesive Agents and Zinc-Pyrrolidone Carboxylic Acid Versus Placebo as an Adjuvant Treatment for Moderate Acne Vulgaris in Indonesia: A Multicenter, Double-blind, Randomized, Controlled Trial [PMID: 32983333 · 2020]
Sitohang IBS, Yahya YF, Simanungkalit R, Adi Winarni DR, Madjid A · J Clin Aesthet Dermatol (2020)

OBJECTIVE: We investigated the efficacy and tolerability of nicotinamide cream plus an antibacterial adhesive agent and zinc-pyrrolidone carboxylic acid compared to placebo in patients with moderate acne vulgaris (MAV) in Indonesia. METHODS: This was a multicenter, double-blind, randomized, placebo-controlled, parallel-group study conducted in five teaching hospitals in Indonesia from August 2016 to January 2017. Eligible participants included 140 patients with MAV, aged 12 to 50 years, who were enrolled and randomly divided into two groups to receive either adapalene and the study formulation or adapalene and a placebo cream twice daily for six weeks. Clinical response and treatment efficacy were assessed through acne lesion counts, presence of side effects, and patient satisfaction at the second, fourth, and sixth weeks after the first visit. RESULTS: A total of 140 subjects from five different centers (28 subjects in each center) were enrolled. One hundred twenty-seven subjects completed the study, including 63 subjects in the study group and 64 subjects in the placebo group. A significant decrease in the number of noninflammatory lesions in the second week was noted in the study group compared to in the placebo group. There were no significant differences in adverse effects between the two groups in the second and fourth weeks. CONCLUSION: Treatment using nicotinamide plus an antibacterial adhesive agent and zinc-pyrrolidone carboxylic acid was effective in reducing noninflammatory lesions by the second week of therapy. ClinicalTrials.gov registration no. NCT0326298.

The mechanisms of action of nicotinamide and zinc in inflammatory skin disease [PMID: 16871773 · 2006]
NIH PubMed Indexed Study · Cutis (2006)

Nicotinamide (niacinamide), a physiologically active form of niacin (nicotinic acid), in combination with zinc is being assessed in clinical studies for the treatment of inflammatory skin diseases such as acne vulgaris and bullous pemphigoid. The basis for these investigations is the variety of potential mechanisms of action of nicotinamide and zinc, including an anti-inflammatory effect via inhibition of leukocyte chemotaxis, lysosomal enzyme release, lymphocytic transformation, mast cell degranulation, bacteriostatic effect against Propionibacterium acnes, inhibition of vasoactive amines, preservation of intracellular coenzyme homeostasis, and decreased sebum production. Other possible mechanisms involve suppression of vascular permeability and inflammatory cell accumulation, as well as protection against DNA damage. The goal of this paper is to review the pathophysiology of inflammatory skin diseases and discuss the role, mechanisms of action, and safety of nicotinamide and zinc as therapeutic options for these disorders.

The role of zinc in the treatment of acne: A review of the literature [PMID: 29193602 · 2018]
NIH PubMed Indexed Study · Dermatol Ther (2018)

Acne vulgaris is a chronic disease of the pilosebaceous units presenting as inflammatory or noninflammatory lesions in individuals of all ages. The current standard of treatment includes topical formulations in the forms of washes, gels, lotions, and creams such as antibiotics, antibacterial agents, retinoids, and comedolytics. Additionally, systemic treatments are available for more severe or resistant forms of acne. Nevertheless, these treatments have shown to induce a wide array of adverse effects, including dryness, peeling, erythema, and even fetal defects and embolic events. Zinc is a promising alternative to other acne treatments owing to its low cost, efficacy, and lack of systemic side effects. In this literature review, we evaluate the effectiveness and side-effect profiles of various formulations of zinc used to treat acne.

Topical azelaic acid, salicylic acid, nicotinamide, sulphur, zinc and fruit acid (alpha-hydroxy acid) for acne [PMID: 32356369 · 2020]
NIH PubMed Indexed Study · Cochrane Database Syst Rev (2020)

Acne is an inflammatory disorder with a high global burden. It is common in adolescents and primarily affects sebaceous gland-rich areas. The clinical benefit of the topical acne treatments azelaic acid, salicylic acid, nicotinamide, sulphur, zinc, and alpha-hydroxy acid is unclear. To assess the effects of topical treatments (azelaic acid, salicylic acid, nicotinamide, zinc, alpha-hydroxy acid, and sulphur) for acne. We searched the following databases up to May 2019: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers. Clinical randomised controlled trials of the six topical treatments compared with other topical treatments, placebo, or no treatment in people with acne. We used standard methodological procedures expected by Cochrane. Key outcomes included participants' global self-assessment of acne improvement (PGA), withdrawal for any reason, minor adverse events (assessed as total number of participants who experienced at least one minor adverse event), and quality of life. We included 49 trials (3880 reported participants) set in clinics, hospitals, research centres, and university settings in Europe, Asia, and the USA. The vast majority of participants had mild to moderate acne, were aged between 12 to 30 years (range: 10 to 45 years), and were female. Treatment lasted over eight weeks in 59% of the studies. Study duration ranged from three months to three years. We assessed 26 studies as being at high risk of bias in at least one domain, but most domains were at low or unclear risk of bias. We grouped outcome assessment into short-term (less than or equal to 4 weeks), medium-term (from 5 to 8 weeks), and long-term treatment (more than 8 weeks). The following results were measured at the end of treatment, which was mainly long-term for the PGA outcome and mixed length (medium-term mainly) for minor adverse events. Azelaic acid In terms of treatment response (PGA), azelaic acid is probably less effective than benzoyl peroxide (risk ratio (RR) 0.82, 95% confidence interval (CI) 0.72 to 0.95; 1 study, 351 participants), but there is probably little or no difference when comparing azelaic acid to tretinoin (RR 0.94, 95% CI 0.78 to 1.14; 1 study, 289 participants) (both moderate-quality evidence). There may be little or no difference in PGA when comparing azelaic acid to clindamycin (RR 1.13, 95% CI 0.92 to 1.38; 1 study, 229 participants; low-quality evidence), but we are uncertain whether there is a difference between azelaic acid and adapalene (1 study, 55 participants; very low-quality evidence). Low-quality evidence indicates there may be no differences in rates of withdrawal for any reason when comparing azelaic acid with benzoyl peroxide (RR 0.88, 95% CI 0.60 to 1.29; 1 study, 351 participants), clindamycin (RR 1.30, 95% CI 0.48 to 3.56; 2 studies, 329 participants), or tretinoin (RR 0.66, 95% CI 0.29 to 1.47; 2 studies, 309 participants), but we are uncertain whether there is a difference between azelaic acid and adapalene (1 study, 55 participants; very low-quality evidence). In terms of total minor adverse events, we are uncertain if there is a difference between azelaic acid compared to adapalene (1 study; 55 participants) or benzoyl peroxide (1 study, 30 participants) (both very low-quality evidence). There may be no difference when comparing azelaic acid to clindamycin (RR 1.50, 95% CI 0.67 to 3.35; 1 study, 100 participants; low-quality evidence). Total minor adverse events were not reported in the comparison of azelaic acid versus tretinoin, but individual application site reactions were reported, such as scaling. Salicylic acid For PGA, there may be little or no difference between salicylic acid and tretinoin (RR 1.00, 95% CI 0.92 to 1.09; 1 study, 46 participants; low-quality evidence); we are not certain whether there is a difference between salicylic acid and pyruvic acid (1 study, 86 participants; very low-quality evidence); and PGA wa

Zinc and sebum excretion [PMID: 4123016 · 1973]
NIH PubMed Indexed Study · Lancet (1973)
Zinc and acne: does it work? [PMID: 159871 · 1979]
NIH PubMed Indexed Study · Int J Dermatol (1979)
Zinc, acrodermatitis, acne, and prostaglandins [PMID: 141314 · 1977]
NIH PubMed Indexed Study · Br Med J (1977)

常见问题解答 (FAQ)

Q1. PCA 锌 (ZINC PCA) 在全球 7 大法域的官方全成分标签名称是什么?
中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名为 'PCA 锌',美国 PCPC 与欧盟 CosIng 标准 INCI 为 'ZINC PCA',日本 JCIA 表示名称为 'ZINC PCA'。
Q2. PCA 锌 (ZINC PCA) 在中、韩、欧、美、日、东盟的法定监管状态 (Layer 1) 如何?
6 大法域监管汇总 — 中国(CN): allowed,韩国(KR): restricted,欧盟(EU): restricted,美国(US): none,日本(JP): none,东盟(ASEAN): none。
Q3. PCA 锌 (ZINC PCA) 的常规配方添加量 (Layer 3) 与最佳稳定 pH 窗口是多少?
在代表性剂型 (aqueous_serum) 中常规添加量为 0.1%–1%(中位数 0.5%),最佳稳定 pH 范围为 4.5–6.5。
Q4. PCA 锌 (ZINC PCA) 有哪些配伍禁忌 (Incompatibilities) 与协同增效组合?
推荐协同组合包括 NIACINAMIDE, SUCCINIC ACID, SALICYLIC ACID, XANTHAN GUM, POLYACRYLATE CROSSPOLYMER-6;配伍禁忌注意:Divalent Zn2+ ion immediately collapses standard Carbomer gels; use Xanthan Gum, Sclerotium Gum, HEC, or SEPIMAX ZEN; Precipitates as insoluble Zinc Hydroxide above pH 7.0; maintain pH 4.8~6.0。