Human recombinant epidermal growth factor in skin lesions: 77 cases in EPItelizando project.

OBJECTIVE: To analyze compounded recombinant human epidermal growth factor (rhEGF) effectiveness on skin lesions through a case series. DESIGN: Multicentric series of skin lesions treated with topical rhEGF. Site: Patients from 56 different health professionals, three different countries, and two recruitment years. PARTICIPANTS: Seventy-seven patients with skin lesions, mean age of 63.15 years (min = 18, max = 95); 53.2% of patients were men and 46.8% were women; 47 of the lesions were ulcers (venous, arterial, and diabetic foot), others were surgical and traumatic wounds, burns, and scars. Most common pathologies were type 2 diabetes mellitus and chronic venous insufficiency. Mean previous evolution time before inclusion was 29.59 months. INTERVENTIONS: Cures using compounded topical rhEGF most commonly used rhEGF concentration: 30 µg/g; most used excipient: gel; average time between cures: 36 h (24-48); and mean follow-up: 6.6 weeks (max = 20). MAIN MEASUREMENTS: Lesions appearance, margins and bed, lesional size evolution, treatment subjective effectiveness, tolerability and comfort through professional oppinion. RESULTS: Qualitative assessment: effectiveness 8.65, tolerability 9.53, and comfort 8.86 (max = 10). Perilesional skin showed improvement in 93.5% of the cases, lesions margins and wound bed appearance improved in 92.2% of the cases, respectively. Wound area decreased a mean average of 66.7%. About 43.3% of included venous ulcers had a greater than 40% cure rate in 4 weeks. LIMITATIONS: Heterogeneity of the included pathologies, limited time follow-up in some cases. CONCLUSIONS: Topical rhEGF in individualized formulation (compounding) seems to exhibit effectiveness, comfort, and tolerability. Further larger-size studies with experimental design will allow to establish more precise concentrations, indications, and clinical guidelines.

Factor de Crecimiento Epidérmico (EGF) y geles de silicona en el abordaje de heridas, quemaduras y cicatrices: revisión de la literatura / Epidermal Growth Factor (EGF) and silicone gels in wounds, burns and scars management: literature review

Introducción y Objetivo. El Factor de Crecimiento Epidérmico (EGF) es conocido desde hace décadas como un elemento formador y de mantenimiento de la piel y diversas mucosas. Se dispone de Factor de Crecimiento Epidérmico recombinante humano (rhEGF), proveniente de técnicas de ingeniería genética, apto para su uso clínico en la prevención o tratamiento de diversas alteraciones cutáneas. El objetivo de este trabajo es realizar una revisión bibliográfica sobre las evidencias disponibles en el uso del rhEGF para el abordaje de lesiones cutáneas. Material y Método. Llevamos a cabo una revisión bibliográfica en los principales buscadores de evidencia científica, incluyendo finalmente en la revisión un total de 25 referencias bibliográficas en relación al uso de rhEGF en la clínica diaria. Resultados. El rhEGF promueve la curación de las heridas (traumáticas o quirúrgicas) y quemaduras, reduciendo la incidencia de cicatrices hipertróficas y queloides. Geles y láminas de silicona son de primera elección en el cuidado de las heridas, agudas o crónicas. El rhEGF está disponible en concentraciones y pureza útiles para uso terapéutico, en galénicas estables y mediante formulación individualizada (formulación magistral); es cómodo, efectivo y seguro, y permite la individualización de tratamientos adicionando principios activos o modificando los vehículos de la fórmula. Conclusiones. Se pueden considerar indicados los compuestos tó- picos con rhEGF comercializados o a través de formulación magistral para el tratamiento de heridas (traumáticas o quirúrgicas), quemaduras, cicatrices hipertróficas y queloides. El rhEGF puede prescribirse con excipientes en gel, serum, crema u otros excipientes tópicos; el gel de silicona puede ser el excipiente más adecuado para maximizar la efectividad del factor, sinergizando la efectividad del gel de silicona y el rhEGF (AU)

Background and Objective. Epidermal Growth Factor (EGF) is known for decades as a building and maintenance element for the skin and several mucous membranes. Recombinant human Epidermal Growth Factor (rhEGF) is available thanks to genetic engineering techniques, and suitable for clinical use in the prevention or treatment of several skin disorders. Our aim is to carry out a literature review on the scientific evidence in the use of rhEGF available for the treatment of skin lesions. Methods. We conduct a bibliographical review using the main scientific evidence search engines, finally including a total of 25 bibliographic references in relation to the use of rhEGF in daily clinical practice. Results. RhEGF promotes wound healing (traumatic or surgical) and burns, reducing the incidence of hypertrophic and keloid scars. Silicone gels and sheets are the first choice in the care of wounds, acute or chronic. RhEGF is available in concentrations and purity useful for therapeutic use, in stable galenics and by individualized formulation (compounding); its use is comfortable, effective and safe, allowing the individualization of treatments adding active principles or modifying the vehicles of the formula. Conclusions. Topical compounds with commercially available rhEGF or by individualized formulation can be considered for the management of wounds (traumatic or surgical), burns, hypertrophic scars and keloids. RhEGF may be prescribed with excipients in gel, serum, cream or other topical excipients; silicone gels may be the most suitable excipient to maximize the effectiveness of the factor, synergizing the effectiveness of the silicone gel and the rhEGF (AU)

Factor de crecimiento epidérmico, innovación y seguridad / Epidermal growth factor, innovation and safety

El recombinant human epidermal growth factor (rhEGF, «factor de crecimiento epidérmico recombinante humano bioidéntico»), disponible en concentraciones y pureza aptas para uso terapéutico, dispone de formulaciones estables en el tiempo. Hay evidencias de efectos terapéuticos beneficiosos en diversas enfermedades y lesiones de la piel (heridas, cicatrices, queloides, dermatitis o alopecia por radiación o por quimioterápicos, hiperpigmentaciones posinflamación o daño causado por la edad), e igualmente puede ser considerado para el tratamiento de algunas afecciones de la mucosa orofaríngea y digestiva alta (aftosis, fístulas faríngeas, mucosas esofágica y gástrica) o para lesiones corneales y conjuntivales. El rhEGF no muestra efectos secundarios o colaterales en humanos ni en animales de experimentación, evidenciando una óptima tolerabilidad y seguridad. La formulación magistral otorga versatilidad, individualización, personalización, estabilidad molecular, seguridad y efectividad en condiciones idóneas, evidenciando una buena capacidad de penetración en el tejido, tanto en piel intacta como sobre lesiones cutáneas que exponen los planos inferiores a la superficie. Se pueden considerar los compuestos con rhEGF para la prevención o tratamiento de diversas afecciones y enfermedades cutáneas o mucosas a través de preparados de formulación magistral (AU)

Bioidentical recombinant human epidermal growth factor (rhEGF) is available in concentrations and purity suitable for therapeutic use in long time stable formulations. Beneficial effects in several skin pathologies and lesions have been reported (traumatic and surgical wound healing, laser induced wounds, abnormal scars, keloids, radiation or chemotherapy induced dermatitis, post inflammatory hyperpigmentation or for skin aging damage repairing) and also may be considered for the treatment of several oropharingeal and high gastroesophageal tract mucosa diseases (mouth sores, pharyngeal fistulas, ulcers), and several corneal or conjunctive mucosa lesions. rhEGF has not shown any important side or collateral effects in humans or in laboratory experimentation animals, showing optimal tolerability and safety with continuous use for months. Compounding gives advantages of versatility, individualization, personalization, molecular stability, safety and effectiveness in ideal conditions, showing good tissue penetration, both on intact skin and skin lesions that expose the lower planes to the surface. rhEGF compounds can be considered for prevention or as a treatment of diverse skin and mucosa diseases and conditions through compounding preparations (AU)

[Epidermal growth factor, innovation and safety]. / Factor de crecimiento epidérmico, innovación y seguridad.

Bioidentical recombinant human epidermal growth factor (rhEGF) is available in concentrations and purity suitable for therapeutic use in long time stable formulations. Beneficial effects in several skin pathologies and lesions have been reported (traumatic and surgical wound healing, laser induced wounds, abnormal scars, keloids, radiation or chemotherapy induced dermatitis, post inflammatory hyperpigmentation or for skin aging damage repairing) and also may be considered for the treatment of several oropharingeal and high gastroesophageal tract mucosa diseases (mouth sores, pharyngeal fistulas, ulcers), and several corneal or conjunctive mucosa lesions. rhEGF has not shown any important side or collateral effects in humans or in laboratory experimentation animals, showing optimal tolerability and safety with continuous use for months. Compounding gives advantages of versatility, individualization, personalization, molecular stability, safety and effectiveness in ideal conditions, showing good tissue penetration, both on intact skin and skin lesions that expose the lower planes to the surface. rhEGF compounds can be considered for prevention or as a treatment of diverse skin and mucosa diseases and conditions through compounding preparations.