Acne Clear Soap (Madame Heng)

Acne Clear Soap (Madame Heng)

Product Name: Мыло от угревой сыпи (акне) с Melaleuca alternifolia (чайное дерево) и Matricaria chamomilla (ромашка аптечная), Acne Clear Soap, Akne-Klärende Seife, Jabón limpiador antiacné, Savon anti-acné, صابون لعلاج حب الشباب, สบู่รักษาสิว, Безёрга қарши совун, Безетки каршы самын, Sızanaqlara qarşı sabun, Собуни зидди доғиҳои пӯст, Muilas nuo spuogų, Ziepes pret pinnēm, Мило проти акне, סבון נגד אקנה

Main Indications for Acne Clear Soap: Acne vulgaris, pustular acne, comedonal acne, papulopustular acne, seborrheic dermatitis, bacterial folliculitis, fungal folliculitis, pityrosporum skin infection, superficial dermatophytosis, staphylococcal impetigo, microbial eczema.

Indications for Acne Clear Soap as Part of Therapeutic Regimens: Papulopustular rosacea, perioral dermatitis, complicated forms of folliculitis, athlete's foot, onychomycosis as part of combination therapy, disseminated staphylococcal skin infection syndrome, secondary pyoderma, squamous cell skin carcinoma, basal cell skin carcinoma, skin melanoma, actinic keratosis.

Main Pharmacological Properties of Acne Clear Soap: antimicrobial, antiseptic, antibacterial, antifungal, anti-inflammatory, antioxidant, sebum-regulating, keratolytic, wound-healing, immunomodulatory, cleansing, soothing.

Composition of Acne Clear Soap: Sodium Palmitate, Aqua (Water), Melaleuca alternifolia Oil (Tea Tree Oil), Matricaria chamomilla Extract (Chamomile Extract), Melaleuca alternifolia Leaf (Tea Tree Leaf), Fragrance.

Functions of the Components in Acne Clear Soap:

• Sodium Palmitate: soap base, provides skin cleansing by emulsifying and removing sebum and impurities.
• Aqua (Water): solvent, forms the soap structure and stabilizes the composition.
• Melaleuca alternifolia Oil (Tea Tree Oil): pronounced antiseptic, antibacterial, and antifungal action, reduces the quantity of Cutibacterium acnes and Staphylococcus aureus.
• Matricaria chamomilla Extract (Chamomile Extract): anti-inflammatory and soothing action, reduces skin redness and irritation, promotes the healing of microdamages.
• Melaleuca alternifolia Leaf (Tea Tree Leaf): additional source of phytoncides and flavonoids, enhancing antibacterial and anti-inflammatory action.
• Fragrance: imparts a light scent to the product, masks the odor of plant components, can be a potential allergen.

Product Form of Acne Clear Soap: the product is available as a solid soap bar weighing 150 g, consisting of a soap base (Sodium Palmitate and Aqua) with a total mass of approximately 135 g and a complex of plant and auxiliary components (tea tree oil, chamomile extract, tea tree leaf, fragrance) with a total mass of approximately 15 g.

Dosage of Acne Clear Soap

Standard Dosage for Acne Clear Soap is recommended for adults with mild to moderate acne vulgaris, comedonal acne, papulopustular acne, and seborrheic dermatitis. Use 1-2 times a day (morning and evening): wet face and body with water, lather soap in hands, apply to skin for 30-60 seconds, then rinse thoroughly with water. Use after meals or irrespective of meal times.

Intensive Dosage for Acne Clear Soap is used in adults during exacerbations of pustular acne, bacterial or fungal folliculitis, microbial eczema. Up to 3 uses per day (morning, afternoon, evening) are allowed. Contact time with the skin can be increased to 90 seconds. Use only as a short-term course (7-10 days), then switch to the standard dosage to avoid excessive skin dryness.

Maximum Dosage for Acne Clear Soap can be used up to 4 times a day in cases of pronounced inflammatory acne, complicated forms of folliculitis, and associated seborrhea. Recommended contact time is up to 2 minutes, with mandatory subsequent use of moisturizers. The maximum dosage should be used short-term (no more than 5-7 consecutive days) and under dermatological supervision.

Pediatric Dosage for Acne Clear Soap is recommended for children over 12 years of age with adolescent acne and seborrheic dermatitis. Use once a day (in the evening) for 20-30 seconds, then rinse thoroughly with water. For children under 12 years of age, data on safety and efficacy are lacking; use is not recommended.

Prophylactic Dosage for Acne Clear Soap is indicated for patients with chronic mild acne, seborrheic dermatitis, predisposition to bacterial or fungal folliculitis. Recommended to use once a day (in the evening), maintaining a long course of up to 2-3 months. Can be used in cases of excessive sweating (hyperhidrosis) and predisposition to clogged pores, in combination with moisturizing care.

Contraindications for Acne Clear Soap is contraindicated in cases of individual hypersensitivity to the components (tea tree oil, chamomile, fragrance). Cross-allergic reactions are possible in patients allergic to plants of the Asteraceae family (chamomile, ragweed, wormwood). Scientifically reliable data on contraindications during pregnancy, lactation, and in children under 12 years of age have not been recorded.

Side Effects of Acne Clear Soap: in case of overdose (excessively frequent use or prolonged contact), the following may occur: skin dryness, irritation, contact dermatitis, allergic reactions (including to tea tree oil or fragrances).

Adjustment for Patient Body Weight: for patients with body weight below 60 kg and above 60 kg, dosage adjustment is not required, as the product is used topically and has no systemic action.

Storage Conditions for Acne Clear Soap: store at a temperature between +5 and +25 °C, in a dry place, away from direct sunlight and heat sources, avoid exposure to moisture and condensation. Avoid storage near sources of strong electromagnetic radiation (EMR). Shelf life is 3 years from the date of manufacture. After opening the package, it is recommended to use the soap within 12 months.

Toxicity and Biosafety — Acne Clear Soap

Scientific data on the toxicity of the finished product in the form of a solid soap are lacking, so the assessment is based on the toxicological characteristics of its active components, taking into account their concentrations and methods of application.

• Melaleuca alternifolia oil (Tea Tree Oil): according to animal data, the median lethal dose (LD₅₀) upon oral administration in mice is 1.9-2.6 g/kg body weight. For topical application at concentrations up to 5%, the oil is considered safe; at higher concentrations, skin irritation and allergic reactions are possible.
• Matricaria chamomilla (Chamomile): chamomile extracts have extremely low acute toxicity, LD₅₀ upon oral administration in rats exceeds 15 g/kg body weight. For external use, chamomile is recognized as safe; no toxic effects have been recorded.
• Sodium palmitate: fatty acid salts are classified as low-toxicity substances, LD₅₀ (oral, rats) is more than 5 g/kg body weight. The main risk is associated with irritant effects on mucous membranes upon ingestion.
• Fragrance: toxicity depends on the specific aromatic compounds. At standard concentrations in cosmetics, systemic toxicity has not been identified; local allergic reactions are possible.

Simulated Cumulative Toxicity of the Product: Given the extremely small amount of active components, their topical use on the skin, and low systemic absorption, the cumulative acute toxicity of the product is assessed as low. The presumed equivalent LD₅₀ level for the combined composition upon oral administration is >5 g/kg body weight (rats), which corresponds to the "low-toxicity substances" category according to the Hodge and Sterner classification.

Conclusion: for external use in recommended regimens, the soap is safe. Potential risks are primarily associated with local skin reactions (irritation, allergic dermatitis). If a large amount of soap is accidentally ingested, gastrointestinal disorders are possible; at very high doses, there is a risk of toxic effects from tea tree oil.

Synergy — Acne Clear Soap

The pharmacological synergy of the components of this product is based on the interaction of the essential oil Melaleuca alternifolia and the extract Matricaria chamomilla in the soap base matrix (Sodium palmitate). Tea tree essential oil, whose main biologically active compound is terpinen-4-ol, has proven antimicrobial activity against a wide range of microorganisms, including gram-positive and gram-negative bacteria, as well as yeast-like and filamentous fungi. Its action is realized through the disruption of cytoplasmic membrane integrity, induction of potassium ion efflux, and impairment of respiratory chains. Chamomile extract, containing α-bisabolol, chamazulene, and flavonoids (apigenin, luteolin, quercetin), demonstrates anti-inflammatory and antioxidant properties by inhibiting NF-κB-dependent signaling cascades, reducing COX-2 and iNOS expression, and modulating the cytokine profile. In combination, both components form a potentiating interaction: the antimicrobial action of tea tree oil is combined with the anti-inflammatory and antioxidant action of chamomile, which reduces the severity of inflammatory reactions caused by microbial colonization. In vitro and in vivo studies indicate an additive and potentiating nature of this interaction: reduction in reactive oxygen species production and suppression of pro-inflammatory mediators enhance the bactericidal action of terpinen-4-ol, preventing tissue damage. Furthermore, the presence of the soap base not only ensures physical removal of microorganisms but also increases the bioavailability of the essential oil through its dispersion, further enhancing its antimicrobial effect. Chamomile contributes a protective modifying effect, reducing the risk of irritant action of tea tree oil components on epidermal cells, which is confirmed by studies on the cytoprotective action of α-bisabolol and chamazulene on keratinocytes. Thus, the overall pharmacological synergy is combined in nature: potentiating (enhancement of antimicrobial and anti-inflammatory effects), protective (reduction of irritant action), and additive (complementary antioxidant properties). Considering in vitro data and clinical observations, this combination can be characterized as a systemic-tissue-specific interaction aimed at modulating inflammatory and microbial processes at the skin level.

References: PMC, PubChem, Semantic Scholar, ScienceDirect, SpringerLink, Wiley Online Library.

Pharmacodynamics of Acne Clear Soap

The pharmacodynamic action of the product is determined by the interaction of the essential oil Melaleuca alternifolia and the extract Matricaria chamomilla in the target dermatological system. Tea tree oil, rich in mono- and sesquiterpenes (mainly terpinen-4-ol, γ-terpinene, α-terpinene), exhibits pronounced antiseptic, antibacterial, and fungistatic properties, acting through the disruption of microbial lipid membranes, inhibition of respiratory chain enzymes, and blocking of biofilm formation. Additionally, terpinen-4-ol reduces the expression of pro-inflammatory cytokines (IL-1β, TNF-α), providing a local anti-inflammatory effect. Chamomile extract contains α-bisabolol and chamazulene, which stabilize cell membranes, reduce the release of histamine and prostaglandins, and inhibit the activity of COX-2 and NO synthase. Chamomile flavonoids have antioxidant action, reducing the generation of reactive oxygen species and preventing oxidative damage to epidermal lipids and proteins. The combination of these mechanisms forms a pronounced local anti-inflammatory, antioxidant, and cytoprotective effect, modulating the activity of skin innate immune cells (keratinocytes, neutrophils, macrophages). The soap base (sodium salts of fatty acids) promotes mechanical removal of lipid substrates, which serve as a nutrient source for pathogenic microorganisms, and enhances the penetration of active phytocompounds into the stratum corneum. The cumulative action of the product is localized at the level of the epidermis and upper dermis, has a tissue-specific character, and is aimed at regulating the skin barrier function, reducing microbial load, decreasing the intensity of the inflammatory response, and preventing tissue damage associated with oxidative stress.

References: PMC, PubMed, Semantic Scholar, ScienceDirect, SpringerLink, Wiley Online Library, WHO monographs.

Pharmacokinetics of Acne Clear Soap

With transdermal application, the volatile terpene components of Melaleuca alternifolia essential oil (primarily monoterpenes) partially evaporate from the skin surface, and absorption through the stratum corneum is limited and increases with occlusion and dispersion in the soap matrix; the absorbed fractions are distributed predominantly in the epidermis/superficial dermis with minimal systemic exposure. In the soap, sodium salts of fatty acids act as carriers, ensuring emulsification of lipophilic molecules and their contact with the stratum corneum; α-bisabolol acts as a mild penetration modifier. The metabolism of terpenes follows a pattern typical for volatile essential oil components: primary oxidation (CYP-dependent Phase I reactions) followed by conjugation (Phase II) and elimination mainly via urine; part of the volatile metabolites and unreacted molecules is eliminated through the lungs. Flavonoids from the Matricaria chamomilla extract (e.g., aglycones like apigenin) upon topical application demonstrate limited penetration, undergo glucuronidation/sulfation, and may be transported via efflux pump proteins; elimination occurs via bile and urine as conjugates. Overall, the soap form is characterized by local action with short contact time and low systemic absorption; the contribution of the skin microbiota involves enzymatic modification of surface components without significant systemic participation.

References: PubMed+1Public Healthsciencedirect.comThiemePMC https://pubmed.ncbi.nlm.nih.go... https://pubmed.ncbi.nlm.nih.go... https://health.ec.europa.eu/do... https://www.sciencedirect.com/... https://www.thieme-connect.de/... https://pmc.ncbi.nlm.nih.gov/a...

Mechanisms of Action and Scientific Rationale: Acne Clear Soap

Liver and Gastrointestinal Tract (Levels: Systemic/Cellular). For the soap form, systemic effects are minimal; for the constituent substances, pathways of oxidative and conjugative metabolism in the liver are described, which determines low accumulation. Chamomile flavonoids (aglycones/conjugates) interact with biotransformation enzyme systems, demonstrating antioxidant and membrane-stabilizing action. Nature of interaction: modulatory. Targets: Phase I/II enzymes, ABC transporters.
References: PMC https://pmc.ncbi.nlm.nih.gov/a...

Immune System (Levels: Tissue-Specific/Cellular). Terpene components of Melaleuca alternifolia oil disrupt microbial membrane integrity and biofilms; concurrently, suppression of NF-κB/MAPK cascades and reduction in the production of inflammatory mediators (cytokines, prostaglandins) are noted. Flavonoids and α-bisabolol enhance anti-inflammatory, antioxidant, and cytoprotective action; nature of interaction:additive/potentiating. Cellular targets: keratinocytes, neutrophils, macrophages.
References: PMC+1journals.asm.org https://pmc.ncbi.nlm.nih.gov/a... https://journals.asm.org/doi/1... https://pmc.ncbi.nlm.nih.gov/a...

Nervous System (Levels: Tissue-Specific/Cellular). For topical application, direct neurotropic effects are not primary; for apigenin, antioxidant and membrane-stabilizing influences mediated by the regulation of ROS and signaling pathways (MAPK, JAK/STAT) have been shown, which affects neuro-cutaneous regulation of sensitivity and barrier function. Nature of interaction: modulatory.
References: onlinelibrary.wiley.com https://onlinelibrary.wiley.co...

Endocrine and Metabolic Regulation (Levels: Systemic/Cellular). Monoterpenes and flavonoids demonstrate mediated influence on redox balance and signaling cascades (NF-κB, NLRP3, MAPK), described as antioxidant and anti-inflammatory direction with an additive nature when terpenes and phenolic compounds are combined. For the soap form, these effects are limited to the local level, complementing the skin's barrier and immune regulation.
References: sciencedirect.com https://www.sciencedirect.com/...

Skin (Levels: Tissue-Specific/Cellular). Terpene components act as membrane-damaging agents for microorganisms, while chamomile flavonoids act as COX-2/iNOS inhibitors and stimulators of barrier differentiation; the soap base provides cleansing of the lipid substrate and dispersion of lipophilic molecules, increasing local availability. In sum — potentiating and protective interaction focused on antimicrobial and anti-inflammatory modulation.
References: PMC+1 https://pmc.ncbi.nlm.nih.gov/articles/PMC1360273/ https://pmc.ncbi.nlm.nih.gov/articles/PMC3626082/