Estudos

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 EPIFACTOR®
Drug delivery de bioestimulação epitelial

DESCRIÇÃO
Substância ativa bioidêntica de natureza peptídica (Epidermal Grow Factor-EGF), sH-Oligopeptídio 1, com elevada
concentração de ácidos graxos oleico e linoleico, que mimetiza o componente de mesmo nome EGF no organismo
humano; sua cadeia, composta por 53 aminoácidos, é obtida por processo biotecnológico de fermentação, através da
bactéria E.Coli.

MECANISMO DE AÇÃO
Epifactor® atua através da sua afinidade com os receptores de EGF, ou seja, o EGFR que estão presentes na
epiderme, derme e matriz de folículos pilosos. A união de Epifactor® com EGFR induz a atividade da tirosina-
quinase, que inicia uma cascata de ações resultando em uma grande sucessão de trocas bioquímicas em toda a
célula, onde entre essas trocas, pode-se destacar a proliferação de queratinócitos, com aumento de sua adesão e
mobilidade, ativação da funcionalidade do fibroblasto, aumentando a produção de colágeno, ácido hialurônico e
elastina, e indução da angiogênese. Assim, estimula a expressão gênica (up-regulation), a capacidade de
recuperação cutânea pela proliferação dos fibroblastos, atenua os sinais do envelhecimento cutâneo, regenera
cicatrizes e contribui com tratamentos a laser, Luz Intensa Pulsada (LIP), peeling e implantes, drug delivery, entre outros.

INDICAÇÕES

 Pós-laser/Peeling/implantes;
 Pré procedimento e cirurgia (preparação cutânea);
 Regeneração cutânea em cicatrizes, feridas e queimaduras;
 Prevenção de queloides e melhora de lesões de acne;
 Prevenção e tratamento de estrias; Anti aging em geral.

DOSE USUAL
Recomendação tópica de 0,004 mg de Epifactor®.

SUGESTÕES DE FÓRMULAS

Epifactor®............................................. 0,004 mg Epifactor®............................................. 0,004 mg

Serum qsp .................................................... 30 g Adimax qsp................................................... 30 g

Modo de uso: aplicação imediata pós Modo de uso: aplicar 2 vezes ao dia, por 30
procedimento. dias.
Indicação: otimização de cicatrização cutânea. Indicação: tratamento e prevenção de
queloides, cicatrização de feridas.

PRINCIPAIS REFERÊNCIAS

SCHOUEST, J.M.; LUU, T.K.; MOY, R.L. Improved texture and appearance of human facial skin after daily topical application of barley produced,
synthetic, human-like epidermal growth factor (EGF) serum. J Drugs Dermatol. V. 11, n. 5, p. 613-620, May 2012. Disponível em: <
http://www.ncbi.nlm.nih.gov/pubmed/?term=Schouest+et+al.+(2012)>. Acesso em: 16 de novembro de 2015, às 18:12.

NIIYAMA, H.; KUROYANAGI, Y. Development of novel wound dressing composed of hyaluronic acid and collagen sponge containing epidermal
growth factor and vitamin C derivative. J Artif Organs. V. 17, n.1, p. 81-87, Mar. 2014. Disponível em:
http://www.ncbi.nlm.nih.gov/pubmed/?term=Niiyama+et+al+(2014)++egf. Acesso em: 16 de novembro de 2015, às 18:18.
 EPIFACTOR®
ESTUDOS CLÍNICOS

Improved texture and appearance of human facial skin after daily topical application of barley produced,
synthetic, human-like epidermal growth factor (EGF) serum

A three month, open-label, single center study was conducted to determine whether a uniquely derived serum
containing barley bioengineered, human-like epidermal growth factor protein could improve visible signs of
photodamage and aging in facial skin. Twenty-nine females, aged 39 to 75 years, with mild to severe, fine and course
rhytids, photodamage, and pigmentation were enrolled. Subjects then applied the treatment serum per the prescribed
protocol twice-daily for 3 months, in addition to the use of a basic sunscreen and facial cleanser. In-person clinical
evaluations and subject self-assessment questionnaires were administered at each follow up visit. In addition, clinical
photography was completed at baseline, and each subsequent visit. Clinical evaluations showed statistically
significant improvement in the appearance of fine lines and rhytids, skin texture, pore size, and various dyschromatic
conditions apparent within the first month of use, and continuing improvement trends for the duration of the study. The
treatment serum was well tolerated with minimal treatment-related complications reported throughout. Efficacy of this
novel serum and treatment protocol resulted in meaningful improvements in photodamage and visible signs of aging.

Development of novel wound dressing composed of hyaluronic acid and collagen sponge containing
epidermal growth factor and vitamin C derivative

This study was designed to investigate the potential of a wound dressing composed of hyaluronic acid (HA) and
collagen (Col) spongy sheet containing epidermal growth factor (EGF) and vitamin C derivative (VC). High-molecular-
weight HA aqueous solution, hydrolyzed low-molecular-weight HA aqueous solution and heat-denatured Col aqueous
solution were mixed, followed by freeze-drying to obtain a spongy sheet. Cross-linkage between Col molecules was
induced by UV irradiation of the spongy sheet (C-wound dressing). In a similar manner, three types of spongy sheet
containing EGF (EGF-wound dressing), containing VC (VC-wound dressing) or containing EGF and VC (EGF·VC-
wound dressing) were prepared by freeze-drying the mixed solution containing the specified components. Cytokine
production by fibroblasts was assessed in a wound surface model using a fibroblast-incorporating Col gel sheet
(cultured dermal substitute; CDS). CDS was elevated to the air-medium interface, onto which each wound dressing
was placed and cultured for 7 days. Fibroblasts in CDS covered with EGF-wound dressing released 3.6 times more
VEGF and 3.0 times more HGF, as compared with the C-wound dressing. Fibroblasts in CDS covered with EGF·VC-
wound dressing released 4.2 times more VEGF and 6.0 times more HGF, as compared with the C-wound dressing.
The efficacy of these wound dressings was evaluated in animal tests using diabetic mice. Each wound dressing was
applied to a full-thickness skin defect on the dorsal area measuring 1.5 × 2.0 cm. After 1 week of application, wound
conditions were evaluated histologically. The EGF·VC-wound dressing more effectively promoted granulation tissue
formation associated with angiogenesis, as compared with other wound dressings.

Wound repair by bone marrow stromal cells through growth factor production

We have previously shown that treatment with bone marrow stromal cells (BMSCs) augments the healing of fascial
wounds in the rat. However, the biochemical mechanism by which BMSCs improve wound healing was not
investigated. Growth factors have been shown to play a key role in repairing damaged tissue. In this study, we
investigated whether BMSCs are capable of producing growth factors that play a critical role in healing of the
damaged tissue. Growth factor expression in BMSCs stimulated with pro-inflammatory cytokines or wound
superfusate was measured by RT-PCR and growth factor-specific quantitative sandwich enzyme-linked
immunosorbent assay (ELISA). RT-PCR analysis demonstrated that BMSCs are capable of expressing transforming
growth factor beta-1 (TGF-beta1), epidermal growth factor (EGF), vascular endothelial growth factor (VEGF) platelet-
derived growth factor (PDGF), keratinocyte growth factor (KGF), fibroblast growth factor (FGF), and hepatocyte
growth factor (HGF) constitutively or upon stimulation with LPS, IL-1alpha, or TNF-alpha. Quantitative analysis of
growth factor production by ELISA showed that BMSCs do not secrete TGF-beta1, EGF or VEGF in response to
uninjured fascia tissue superfusate; however, production of these growth factors is significantly increased when cells
were stimulated with wound tissue superfusate. The ability of wound to stimulate growth factor production in BMSCs
could be detected as early as day 1 and lasted through day 7 after wounding. Thus, growth factor production by
BMSCs in response to wound microenvionment suggests that BMSCs might augment wound healing through the
responsive secretion of growth factors that enhance angiogenesis and promote wound repair.

Em um estudo clínico, foi avaliada a eficácia de Epifactor® comparado ao placebo na atividade regeneradora da
barreira cutânea pós-laser CO2 fracionado. Observaram-se parâmetros de tempo de reepitelização, vermelhidão e
irritação cutânea. O estudo evidenciou que o uso do Epifactor® não impediu os benefícios do laser CO² fracionado;
pelo contrário, contribuiu para a eficácia do tratamento. Concluiu-se uma melhora mais rápida na regeneração da
pele, menos eritema e maior conforto para o paciente no tempo de repouso.

Referência de dados baseada em estudos do próprio fornecedor.

Efficacy of topical application of beta urogastrone (recombinant human epidermal growth factor) in Wagner's
Grade 1 and 2 diabetic foot ulcers: Comparative analysis of 50 patients

Introduction: Diabetes mellitus is growing at epidemic proportions world wide and associated with this is an increase
in incidence of diabetic foot ulcers. For better understanding and ease of management, diabetic foot ulcer severity is
often classified using the Wagner system. In recent times, various treatment modalities have been put to test for
getting early wound healing, including growth factors like human epidermal growth factor.Materials and methods: The
present study was conducted in the Department of Surgery, Dayanand Medical College and Hospital, Ludhiana. The
patients were divided into two groups of 25 patients each. Group 1 was the study group and patients in this group
received topical application of beta urogastrone (rhEGF) gel. Group 2 was the control group and patients in this group
received betadine dressing. The patients were followed up after every two weeks for eight weeks.RESULTS:The age
and sex were comparable in both groups. Mode of onset was either spontaneous or posttraumatic or following
debridement. Initially in group A, 12 patients each had serous and seropurulent discharge respectively. I patient did
not have any discharge. In group B, 15 patients had sero purulent discharge, 9 patients had serous discharge and 1
patient had purulent discharge. Initially, 13 patients in group A and 15 patients in group B had granulation tissue.
Mean size at the beginning of the study in-group A was 19.56 sq cm and 21.20 sq cm in group B. Two patients from
group A had incomplete healing at the end of the study as compared to 14 patients from group B.
Conclusions:The application of rhEGF shortens the wound healing time significantly and the mean closure was
significantly higher in the EGF group compared with placebo.
Growth factor therapy in patients with partial-thickness burns: a systematic review and meta-analysis

Growth factor (GF) therapy has shown promise in treating a variety of refractory wounds. However, evidence
supporting its routine use in burn injury remains uncertain. We performed this systematic review and meta-analysis
assessing randomised controlled trials (RCTs) to investigate efficacy and safety of GFs in the management of partial-
thickness burns. Electronic searches were conducted in PubMed and the Cochrane databases. Endpoint results
analysed included wound healing and scar formation. Thirteen studies comprising a total of 1924 participants with
2130 wounds (1131 GF receiving patients versus 999 controls) were identified and included, evaluating the effect of
fibroblast growth factor (FGF), epidermal growth factor (EGF) and granulocytemacrophage-colony stimulating factor
(GM-CSF) on partial-thickness burns. Topical application of these agents significantly reduced healing time by 5·02
(95% confidence interval, 2·62 to 7·42), 3·12 (95% CI, 1·11 to 5·13) and 5·1 (95% CI, 4·02 to 6·18) days, respectively,
compared with standard wound care alone. In addition, scar improvement following therapy with FGF and EGF was
evident in terms of pigmentation, pliability, height and vascularity. No significant increase in adverse events was
observed in patients receiving GFs. These results suggested that GF therapy could be an effective and safe add-on to
standard wound care for partial-thickness burns. High-quality, adequately powered trials are needed to further confirm
the conclusion.

REFERÊNCIAS
SCHOUEST, J.M.; LUU, T.K.; MOY, R.L. Improved texture and appearance of human facial skin after daily topical application of barley produced,
synthetic, human-like epidermal growth factor (EGF) serum. J Drugs Dermatol. V. 11, n. 5, p. 613-620, May 2012. Disponível em: <
http://www.ncbi.nlm.nih.gov/pubmed/?term=Schouest+et+al.+(2012)>. Acesso em: 16 de novembro de 2015, às 18:12.

NIIYAMA, H.; KUROYANAGI, Y. Development of novel wound dressing composed of hyaluronic acid and collagen sponge containing epidermal
growth factor and vitamin C derivative. J Artif Organs. V. 17, n.1, p. 81-87, Mar. 2014. Disponível em:
http://www.ncbi.nlm.nih.gov/pubmed/?term=Niiyama+et+al+(2014)++egf. Acesso em: 16 de novembro de 2015, às 18:18.

LIU, Y. et. al. Wound repair by bone marrow stromal cells through growth factor production. J Surg Res. V. 136, n. 2, p. 336-341, Dec 2006
Disponível em:< http://www.ncbi.nlm.nih.gov/pubmed/?term=Kwon+et+al.+(2006)++egf>. Acesso em: 16 de novembro de 2015, às 18:25.

Referência de dados baseada em estudos do próprio fornecedor.

SINGLA, S. Et. al. Efficacy of topical application of beta urogastrone (recombinant human epidermal growth factor) in Wagner's Grade 1 and 2
diabetic foot ulcers: Comparative analysis of 50 patients. J Nat Sci Biol Med. v. 5, n. 2, p. 273-277, Jul 2014. Disponível em:<
http://www.ncbi.nlm.nih.gov/pubmed/25097397>. Acesso em: 04 de janeiro de 2016, às 14:23.

ZHANG, Y. et. al. Growth factor therapy in patients with partial-thickness burns: a systematic review and meta-analysis. Int Wound J 2014.
Disponível em: < http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0069967/>. Acesso em: 04 de janeiro de 2016, às 14:29.