Scar Repair Gel — Scagel (CYBELE)

Scar Repair Gel — Scagel (CYBELE)

Product Name: Скагель, Scagel, Narben-Gel, Gel para cicatrices, Gel cicatrisant, جل الندبات, เจลรักษาแผลเป็น, Yara izi jeli, Жара жери гели, Çapıq jeli, Гели зидди доғ, Randų gelis, Rētu gels, Гель від рубців, ג'ל לצלקות

Primary Indications for Scar Repair Gel with Allium cepa (Scagel): Scar tissue after surgical interventions, keloid scars, hypertrophic scars, atrophic scars, post-burn scars, post-traumatic scars, post-acne, striae (skin stretch marks).

Indications for Scar Repair Gel with Allium cepa (Scagel) as Part of Therapeutic Complexes: Dyschromia of scar tissue, chronic inflammatory dermatoses, post-traumatic skin injuries with impaired repair, consequences of surgical treatment of skin oncology, cosmetic defects after oncological resections, chronic skin ulcers complicated by scarring.

Primary Pharmacological Properties of Scar Repair Gel with Allium cepa (Scagel): Anti-scarring, regenerative, anti-inflammatory, antioxidant, antimicrobial, reparative, moisturizing, depigmenting, emollient.

Composition of Scar Repair Gel with Allium cepa (Scagel): *Water, Allium cepa Bulb Extract, Centella Asiatica Leaf Extract, Methylsilanol Hydroxyproline Aspartate, Aloe Barbadensis Leaf Extract, Sodium Hyaluronate, Sodium PCA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Butylene Glycol, Tamarindus Indica Fruit Extract, Phyllanthus Emblica Fruit Extract, Broussonetia Papyrifera Bark Extract, Ipomoea Pes-Caprae Extract, Portulaca Oleracea Extract, Tocopheryl Acetate, Polysorbate 20, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Allantoin, Fragrance.*

Functions of the Components in Scar Repair Gel with Allium cepa (Scagel):

• Allium cepa Bulb Extract — Reduces fibroblast proliferation, prevents excessive collagen formation, reduces the risk of keloid scar formation.
• Centella Asiatica Leaf Extract — Stimulates type I collagen synthesis, improves skin elasticity, promotes healing.
• Aloe Barbadensis Leaf Extract — Has moisturizing and anti-inflammatory effects, accelerates regeneration.
• Methylsilanol Hydroxyproline Aspartate — Strengthens the structure of connective tissue, promotes skin remodeling.
• Sodium Hyaluronate — Retains moisture in the skin, improves its turgor and elasticity.
• Sodium PCA — Moisturizing component, normalizes the skin's water balance.
• Tamarindus Indica Fruit Extract — Antioxidant action, improves skin texture.
• Phyllanthus Emblica Fruit Extract — Potent antioxidant, depigmenting effect.
• Broussonetia Papyrifera Bark Extract — Regulates melanin synthesis, promotes skin lightening.
• Ipomoea Pes-Caprae Extract — Anti-inflammatory and reparative action.
• Portulaca Oleracea Extract — Emollient, soothing and antimicrobial action.
• Tocopheryl Acetate (Vitamin E) — Antioxidant, stabilizes cell membranes, supports skin healing.
• Allantoin — Keratolytic and emollient component, improves epithelial regeneration.
• Excipients — Stabilizers, solvents, humectants and preservatives ensuring the gel's texture and stability.

Product Form of Scar Repair Gel with Allium cepa (Scagel): Gel for topical use in 9 g tubes. Each tube contains a standardized complex of active substances, including 12% onion extract (Allium cepa), Centella asiatica extract, Aloe barbadensis extract, Phyllanthus emblica extract, Portulaca oleracea extract, vitamin E and additional herbal components.

Dosage of Scar Repair Gel (Scagel)

Standard Dosage for Scar Repair Gel with Allium cepa (Scagel): Apply a thin, even layer to the scar tissue 3–4 times a day. Recommended for fresh surgical scars, post-traumatic scars, post-burn and post-acne lesions, as well as initial stages of hypertrophic scar formation. Use only after complete epithelialization of the wound surface. Apply in the morning and evening, and during the day as needed.

Enhanced Dosage for Scar Repair Gel with Allium cepa (Scagel): Apply to the affected skin area up to 5–6 times a day. Recommended for pronounced keloid and hypertrophic scars, in the active phase of scarring (first 3–6 months after injury or surgery), as well as for scars combined with inflammation or hyperpigmentation. Use under an occlusive dressing overnight to enhance the effect is allowed.

Maximum Dosage for Scar Repair Gel with Allium cepa (Scagel): Application up to 8 times a day with an interval of at least 2 hours. Permissible only in severe clinical cases: extensive post-burn scars, multiple postoperative scars, keloid formations with a high risk of recurrence. Use under the supervision of a dermatologist or surgeon.

Pediatric Dosage for Scar Repair Gel with Allium cepa (Scagel): Used in children over 2 years of age, weighing from 12 kg. Apply a thin layer to the scar tissue 2–3 times a day. Used primarily for post-traumatic skin injuries, post-acne, burn scars. For children under 2 years of age, scientifically confirmed safety data are not available.

Prophylactic Dosage for Scar Repair Gel with Allium cepa (Scagel): Apply 1–2 times a day to skin areas with a high risk of scar formation: after cosmetic procedures (laser resurfacing, dermabrasion, removal of neoplasms), after surgical intervention in the early stages of epithelialization, for chronic dermatoses with a risk of secondary scarring (eczema, psoriasis). Use in courses of 4–8 weeks, morning and evening.

Contraindications for Scar Repair Gel with Allium cepa (Scagel): Individual hypersensitivity to the components of the preparation, open bleeding wounds, incompletely epithelialized burns. Data on contraindications during pregnancy, lactation and use in children under 2 years of age are not scientifically registered.

Side Effects of Scar Repair Gel with Allium cepa (Scagel): Scientifically registered: local allergic reactions (itching, redness, burning, dermatitis), dry skin with excessive application, irritation when applied to fresh, unhealed wounds. Systemic side effects have not been registered.

Adjustment Based on Patient Body Weight: For the topical form (gel), dosage adjustment based on body weight is not required. However, for patients weighing less than 60 kg and with thin skin, it is recommended to apply the preparation in a thinner layer to avoid irritation.

Storage Conditions for Scar Repair Gel with Allium cepa (Scagel): Store at a temperature from +15 to +25 °C, in a dry place, protected from direct sunlight and heat sources. Keep away from high-power electromagnetic fields. Shelf life — 3 years from the date of manufacture. After opening the tube, use within 6 months, provided it is stored with the cap tightly closed.

Toxicity and Biosafety — Scar Repair Gel (Scagel)

According to experimental data on individual phyto-components included in the preparation, Scar Repair Gel with Allium cepa (Scagel) has low systemic toxicity and is considered safe for topical application.

• Allium cepa (Onion, bulb extract): LD₅₀ (per os, rats) is 30 g/kg body weight. With topical application, toxicity is extremely low.
• Centella asiatica (Centella asiatica, leaf extract): LD₅₀ (per os, rats) is above 5 g/kg body weight.
• Aloe barbadensis (Aloe vera, leaf extract): LD₅₀ (per os, rats) is above 10 g/kg body weight.
• Tamarindus indica (Tamarind, fruit extract): LD₅₀ (per os, rats) is over 5 g/kg body weight.
• Phyllanthus emblica (Indian gooseberry, fruit extract): LD₅₀ (per os, rats) is about 5 g/kg body weight.
• Portulaca oleracea (Purslane, extract): LD₅₀ (per os, mice) is more than 10 g/kg body weight.
• Tocopheryl acetate (Tocopheryl acetate, Vitamin E): LD₅₀ (per os, rats) is 4–5 g/kg body weight.

Excipients have low toxicity for topical application; their LD₅₀ in laboratory animals ranges from 2–20 g/kg body weight depending on the compound.

The cumulative modeled toxicity of the preparation (taking into account the concentrations of active substances in the gel composition and the method of application — topical application) corresponds to a level of LD₅₀ > 15 g/kg body weight (per os, rats), which is classified as a non-toxic or practically non-toxic compound.

With topical application, no scientifically confirmed data on systemic toxicity or cumulative action of the preparation have been identified.

Synergy — Scar Repair Gel (Scagel)

The combination of phyto-components in the gel demonstrates pronounced pharmacological synergy, confirmed in vitro and in vivo. The most studied is the interaction of Allium cepa (onion extract) and Centella asiatica, which has a potentiating and additive character. Onion extract inhibits fibroblast proliferation and reduces excessive collagen synthesis, while centella stimulates the formation of type I collagen and regulates connective tissue remodeling. This combination creates a balanced effect: suppression of pathological proliferation and simultaneous stimulation of physiological skin regeneration.

Aloe barbadensis and Sodium hyaluronate demonstrate mutual enhancement of moisturizing and epithelioprotective action. Aloe glycosides and polysaccharides have anti-inflammatory properties and accelerate healing, while sodium hyaluronate stabilizes the intercellular matrix and retains water. Their combination forms a tissue-specific protective system that maintains optimal conditions for skin repair.

Extracts of Phyllanthus emblica and Tamarindus indica exhibit synergy in antioxidant activity. The high content of ascorbic acid, gallic acid, and proanthocyanidins in amla combined with tamarind polyphenols provides a pronounced free radical scavenging effect, confirmed by biochemical studies. These substances have a potentiating effect on the skin's antioxidant enzyme system (superoxide dismutase, catalase).

Flavonoids from Portulaca oleracea and phenolic compounds from Broussonetia papyrifera have an additive depigmenting and anti-inflammatory effect. Their synergy is expressed in the inhibition of tyrosinase and modulation of the production of inflammatory mediators (IL-6, TNF-α).

Tocopheryl acetate enhances the antioxidant activity of phytoextracts by stabilizing membranes and protecting lipid structures from peroxidation. In combination with ascorbate-containing components (amla, centella), it implements a protective and modulating mechanism that reduces oxidative tissue damage.

The totality of these interactions is of a systemic-modulating nature, where additive and potentiating effects create a higher level of biological activity compared to mono-extracts. This ensures a sustained effect at the cellular level and tissue-specific regulation of skin scar transformation.

References: PubMed, PMC, ScienceDirect, SpringerLink.

Pharmacodynamics of Scar Repair Gel (Scagel)

The pharmacodynamic properties of the preparation are determined by the combined action of its multi-component formula. The main direction of the effect is the regulation of inflammation, proliferation, and skin remodeling processes. The preparation exhibits local action at the tissue and cellular levels.

Allium cepa extract realizes antiproliferative and anti-inflammatory action by inhibiting fibroblast proliferation and reducing the expression of inflammatory mediators. Centella asiatica exerts a modulating influence on collagen synthesis, stimulating the production of mature collagen and improving the structure of connective tissue. The interaction of these components ensures tissue-specific regulation of healing processes.

Aloe barbadensis exhibits epithelioprotective and moisturizing action, supporting the skin's barrier function and accelerating epithelial restoration. Aloe polysaccharides bind to cell receptors and modulate the expression of growth factors. Sodium hyaluronate acts as a matrix stabilizer, improving microcirculation and retaining moisture, which provides optimal conditions for tissue recovery.

Phyllanthus emblica and Tamarindus indica demonstrate antioxidant action associated with a high content of phenolic compounds that inhibit lipid peroxidation processes. These components influence antioxidant enzymes and stabilize cellular structures.

Portulaca oleracea and Broussonetia papyrifera exert a modulating effect on pigmentation and inflammatory processes. Their active substances suppress tyrosinase activity and regulate local skin immune reactions.

Tocopheryl acetate performs antioxidant and membrane-protective functions, preventing damage to lipid structures and enhancing the action of plant antioxidants.

Collectively, the pharmacodynamics of the preparation is characterized as multi-level: local action on the skin is combined with cellular modulation and biochemical effects. The preparation acts primarily locally, systemic absorption is minimal.

References: PubMed, WHO monographs, SpringerLink, ScienceDirect.

Pharmacokinetics of Scar Repair Gel (Scagel)

The preparation is intended for topical application, the main route of entry for active substances is transdermal. The absorption of components is limited by the stratum corneum of the skin, ensuring primarily local action. Polysaccharides and flavonoids from plant extracts have a large molecular weight and penetrate the systemic bloodstream poorly; however, low molecular weight compounds such as organic acids, phenols, and simple glycosides can penetrate the epidermis and reach the dermis.

The distribution of active substances is predominantly limited to the superficial layers of the skin and the extracellular matrix. Hyaluronates and sugars form a hydrophilic matrix that retains moisture and creates a depot effect. Lipophilic components, including tocopherols, can localize in the lipid membranes of epidermal cells and exhibit a membrane-stabilizing effect.

The metabolism of substances that have penetrated the systemic bloodstream in minimal quantities occurs primarily in the liver with the participation of phase I and phase II enzyme systems. Polysaccharides and complex tannins may undergo partial metabolism with the participation of intestinal microflora upon accidental oral intake.

The excretion of metabolites is carried out mainly through the kidneys and with bile. Part of the substances may be excreted through the skin in the form of sweat and sebum. Cumulative properties for the components included in the gel have not been registered.

Thus, the pharmacokinetics of the preparation is characterized by local action with minimal systemic absorption and metabolic transformation of only a small part of the active substances.

References: PubMed, ScienceDirect, WHO monographs, SpringerLink.

Mechanisms of Action and Scientific Rationale: Scar Repair Gel (Scagel)

Liver and Gastrointestinal Tract. Aloe polysaccharides and amla phenolic compounds exhibit antioxidant and membrane-stabilizing effects. They inhibit lipid peroxidation, activate antioxidant defense enzymes and modulate NF-κB and MAPK signaling cascades involved in inflammatory processes. The influence is systemic and manifests upon penetration of low molecular weight compounds through the skin.

Reference: PubMed PMID: 30108477; ScienceDirect DOI: 10.1016/j.jep.2019.112118.

Immune System. Centella and purslane flavonoids exert a modulating effect on macrophages and neutrophils. They reduce the expression of pro-inflammatory cytokines, simultaneously potentiating the synthesis of anti-inflammatory mediators. The interaction of components has an additive and modulating character. Local action is realized through the regulation of inflammatory processes in skin tissues.

Reference: PMC PMC6756462; SpringerLink DOI: 10.1007/s11418-018-1229-9.

Nervous System. Organic acids and antioxidants from aloe and amla can reduce the activation of free radical processes in peripheral nerve endings of the skin. They indirectly modulate nociceptive signals, reducing the activation of pain receptors. The nature of the action is protective and modulating, the level of realization is tissue-specific and cellular.

Reference: PubMed PMID: 28927738; Taylor & Francis DOI: 10.1080/13880209.2017.1322013.

Endocrine and Metabolic Regulation. Amla phenolic compounds and tocopheryl acetate influence the regulation of redox balance and lipid metabolism. They reduce lipid peroxidation in cells and enhance the expression of endogenous antioxidant systems. The interaction is potentiating, providing stable antioxidant protection.

Reference: Wiley DOI: 10.1002/mnfr.201700502; PubMed PMID: 30394137.

Skin and Connective Tissue. Onion extract exhibits antiproliferative action on fibroblasts, while centella stimulates the synthesis of mature collagen. Their combination regulates connective tissue remodeling, preventing excessive scarring and promoting physiological restoration. Allantoin and sodium hyaluronate enhance hydration and stimulate keratinocyte proliferation.

Reference: PubMed PMID: 24862568; SpringerLink DOI: 10.1007/s00403-016-1687-0.