Treatment of moderate to severe acne vulgaris with an oral isotretinoin similar to the reference product

Picosse, Fabíola Rosa; Bonatto, Danielle Cristine; Hassun, Karime Marques; Filho, Sérgio Talarico; Azulay, David Rubem; Bagatin, Ediléia

doi:10.5935/scd1984-8773.201682814

Cited by 6 publications

(9 citation statements)

References 25 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Screening of the reference lists of these papers resulted in one additional study, making the total 255. Of these 254 were excluded …”

Section: Resultsmentioning

confidence: 99%

“…Studies that only used the PROM as an outcome measurement instrument were excluded, but study details were tabulated, per protocol. We identified 188 studies that reported treatment satisfaction as an outcome: 91 on treatment of acne 68–158 and 97 on treating acne scars (a possible sequela of acne) 159–255 . These numbers show that clinicians and researchers do consider treatment satisfaction as an important outcome.…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Identifying and appraising patient‐reported outcome measures on treatment satisfaction in acne: a systematic review*

Zuuren

Arents²,

Miklas

et al. 2020

Br J Dermatol

View full text Add to dashboard Cite

Background After dermatitis, acne is the next skin disease to contribute most to the burden of skin diseases worldwide. Recently, seven core outcome domains have been identified, which together form an Acne Core Outcome Set (ACORN). One of these was satisfaction with acne treatment. Objectives To identify studies that described the development of patient-reported outcome measures (PROMS), evaluated one or more measurement properties of a PROM, or evaluated the interpretability of a PROM in patients with acne regarding treatment satisfaction. Methods The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) search strategy for identifying PROMS on acne treatment satisfaction was used. We searched PubMed, MEDLINE, Embase, LILACS, Web of Science, Cochrane Library, Emcare, PsycINFO and Academic Search premier (June 2020). Study selection, data extraction and assessment of methodological quality according to COSMIN guidance were carried out independently by two authors. Results Only one study could be included, describing the development of a treatment satisfaction measure in patients with acne. The development was assessed as inadequate and data on measurement properties were lacking. Additionally, we found 188 studies reporting treatment satisfaction solely as an outcome, using a wide variety of methods, none of them standardized or validated. Conclusions We could not find a PROM on treatment satisfaction to recommend for a core outcome set in acne. There is an unmet need for a PROM on treatment satisfaction in acne that is robustly developed, designed and validated.What is already known about this topic?• Core outcome sets are consensus-based minimum outcome measures that should be reported in clinical trials of a specific disease or target condition.

show abstract

“…Screening of the reference lists of these papers resulted in one additional study, making the total 255. Of these 254 were excluded …”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Identifying and appraising patient‐reported outcome measures on treatment satisfaction in acne: a systematic review*

Zuuren

Arents²,

Miklas

et al. 2020

Br J Dermatol

View full text Add to dashboard Cite

show abstract

“…Além disso, a eliminação de medicamentos contendo esse princípio ativo é lenta, de forma que, no mínimo durante 30 dias após o uso é necessário evitar a gravidez 16,23 , sendo ainda importante a assinatura do Termo de Consentimento Informado, demonstrando ciência dos riscos 24 .…”

Section: Resultsunclassified

Uso de isotretinoína por mulheres em idade reprodutiva

Júnior¹,

Lima²,

Menezes³

et al. 2019

Arch Health Invest

View full text Add to dashboard Cite

Introdução: A isotretinoína é um fármaco amplamente utilizado e efetivo para o tratamento de acne. Porém, é necessário avaliar minuciosamente a relação de risco x benefício em seu uso, uma vez que, mulheres em idade reprodutiva podem sofrer com abortos ou embriopatias e os seus efeitos adversos podem atingir diversos sistemas corporais. Objetivo: O presente estudo teve como objetivo realizar uma revisão de literatura acerca dos riscos inerentes ao uso de isotretinoína por mulheres em idade fértil, ressaltando as possíveis reações adversas atreladas a esta terapia medicamentosa. Materiais e métodos: Trata-se de uma revisão bibliográfica do tipo integrativa em que houve a utilização de artigos, livros, dissertações e teses publicados entre os anos de 2008 a 2018. Resultados: De 165 estudos recuperados, somente 11 artigos foram utilizados para a construção dos resultados. Em 100% das pesquisas observou-se que havia mulheres em idade reprodutiva estando, portanto, susceptíveis a desenvolver embriopatias ou aborto. Como principais efeitos adversos, implicações relacionadas aos sistemas cardiovascular (18,2%), hepático (27,3%) e alterações no lipidograma (36,4%) foram observadas, ocasionando em possível necessidade do monitoramento dessas pacientes. Conclusão: O perfil de usuárias de isotretinoína foi de mulheres em idade reprodutiva. Em relação aos efeitos adversos, torna-se imprescindível o desenvolvimento de estudos a longo prazo para se elucidar se este fármaco pode contribuir para o desenvolvimento de doenças cardíacas, hepáticas e dislipidemias.Descritores: Farmacologia; Preparações Farmacêuticas; Saúde da Mulher.ReferênciasMahto A. Acne vulgaris. Medicine. 2017;45(6):386-89.Saint-Jean M, Dreno B. Acné. EMC Dermatología. 2016,50(4):1-14.Tan AU, Schlosser BJ, Paller AS. A review of diagnosis and treatment of acne in adult female patients. Int J Womens Dermatol. 2017;4(2):56-71.Mahmood NF, Shipmam AR. The age-old problem of acne. Int J Womens Dermatol. 2016;3(2):71-6.Le Moigne M, Saint-Jean M, Dreno B. Acné. EMC Tratado de Medicina. 2017;21(3):1-8.Berbis P. Acitrétine. Ann Derm Ven. 2001; 128(6-7):737-45.Silva Júnior ED, Sette IMF, Belém LF, Jenebro DI, Pereira GJS, Barbosa JAA et al. Isotretinoína no tratamento da acne: riscos x benefícios. Rev Bras Farm. 2009;90(3):186-89.Rodrigues EP, Gontijo EEL, Silva MG. Perfil dos pacientes com acne tratados com isotretinoína atendidos na clínica de dermatologia e laser o período de 2009 e 2012, na cidade de Gurupi, Tocantins. Rev ITPAC. 2014;7(3).Alan S, Ünal B, Yildirim A. Premature ventricular contractions associated with isotertinoin use. An Bras Dermatol. 2016;91(6):820-21.Borges MB, Ribeiro RKB, Costa FPP, Cavalcante JC. Avaliação laboratorial do perfil lipídico e testes de lesão hepatocelular em pacientes com acne vulgar sob uso de isotretinoína oral. Rev Soc Bras Clin Méd. 2011;9(6):397-402.Bravo BSF, Azulay DR, Luiz RR, Mandarim-de-Lacerda CA, Cuzzi T, Azulay MM. Oral isotretinoin in photoaging: objective histological evidence of efficacy and durability. An Bras Dermatol. 2015;90(4):478-86.Brito MFM, Sant’Anna IP, Galindo JCS, Rosendo LHPM, Santos JB. Avaliação dos efeitos adversos clínicos e alterações laboratoriais em pacientes com acne vulgar tratados com isotretinoína oral. An Bras Dermatol. 2010;85(3):331-37.Coghi S, Neves MC. Hidratação nasal e tratamento da pele. RBM. 2011;68(3,suppl):15-21.Cunha Filho RR, Almeida Júnior HL, Breuning JA. Angiodema duo to oral acitretin and isotretinoin. An Bras Dermatol. 2011;86(4 suppl 1):28-30.Kartal D, Yarsar M, Kartal L, Özcan I, Borlu M. Effects of isotretinoin on the olfactory function in patients with acne. An Bras Dermatol. 2017;92(2):191-95.Picosse FR, Bonatto DC, Hassun KM, Talarico Filho S, Azulay DR, Bagatin E. Treatment of moderate to severe acne vulgaris with an orol isotretinoin similar to the reference product. Surg Cosmet Dermatol. 2016,8(2):121-27.Rojas PG, Lopez RG, Chehade AC, Scavino Y, Morales A, Tagle M. Hepatitis autoinmune inducida por isotretionina. Rev gastroenterol Peru. 2016;36(1):86-9.Schmitt JV, Tavares M, Cerci FB. Mulheres adultas com acne apresentam maior risco de elevação de triglicerídeos ao uso de isotretinoína oral. An Bras Dermatol. 2011;86(4):807-10. Vieira AS, Beijamini V, Melchiors AC. The effect of isotretinoin on triglycerides and liver aminotransferases. An Bras Dermatol. 2012;87(3):382-87.Brasil. Ministério da saúde. Protocolo clínico e diretrizes terapêuticas – Acne grave. 2010. Disponível em:< http://conitec.gov.br/images/pdf/2014/abril/02/pcdt-acne-livro-2010.pdf>. Acesso em: 4 jul. 2018.Brasil. Ministério da Saúde. Planejamento Familiar. 2011. Disponível em:< http://www.brasil.gov.br/editoria/saude/2011/09/planejamento-familiar>. Acesso em: 30 mai. 2018.Cammarta-Scalisi F, Nieves D, Avendaño A, Lacruz-Rengel MA, Alviárez K, Dávila F et al. Embriopatía por isotretinoína. Una entidad que puede evitarse. Arch Argent Pediatr. 2018;116(2):e303-7.Lima GHS, Jubé MRR, Feres CC, Watanabe LE, Souza AMC. Embriopatia de ácido retinóico: relato de dois casos associados ao uso da istretinoína. Acta Fisiatr. 2008;15(1):59-62.Cajueiro ES, Lima LBR, Partata AK. Isotretinoína e suas propriedades farmacológicas. Rev ITPAC. 2014;7(1).Xavier HT, Izar MC, Faria Neto JR, Assad MH, Rocha VZ, Sposito AC et al. V diretriz brasileira de dislipidemias e prevenção da aterosclerose. Arq Bras Cardiol. 2013;101(4):1-20.Francisco AR, Gonçalves I, Veiga F, Pedro MM, Pinto FJ, Brito D. Hipertrigliceridemia: há um papel para a aferese profilática? Relato de caso. Braz J Nephrol (J Bras Nefrol). 2016;38(3):366-69.Mendes VS, Costa FO, Oliveira PAD, Oliveira AMSD. Efeitos do uso de isotretinoín ae acitretina nos tecidos bucais – revisão de literatura. Arq bras odontol. 2016;12(1):1-8.Pina M, Canto GS. Atenção farmacêutica em dermatologia: fármacos e antiacneicos. Saúde (Santa Maria). 2010;36(2):39-54.Medeiros RC, Dantas VCR, Barbosa MFPP, Figueiredo IFQ, Silva SAM. Avaliação laboratorial de pacientes que fazem uso de isotretinoína oral para o tratamento da acne grave. Rev bras anal clin. 2014;46(1-4):54-58.Pachajoa H, Ordoñez A. Embriopatía por isotretinoína con microtia-anotia y cardiopatía. Presentación de un caso. Arch argent pediatr. 2012;110(3):e47-9.Silva LN, Alves LR, Barbosa TS, Santos TSB, Gomes MN, Fernandes CKC. Acompanhamento farmacoterapêutico do uso da isotretinoina. Rev Fac Montes Belos (FMB). 2014;7(1):121-35.Silva NF. Atenção farmacêutica em gestantes [trabalho de conclusão de curso]. Araraquara: Graduação em Farmácia pela Universidade Estadual Paulista; 2013.

show abstract

“…Particularly, oral isotretinoin looks more effective at achieving prolonged remission after treatment than other choices such as oral antibiotics, making it a potentially more durable option for acne patients. This study has significant implications for the current and future management of patients with hormonal or environmental acne [19,21,22].…”

Section: Discussionmentioning

confidence: 97%

“…These processes limit the proliferation of Propionibacterium acnes, a critical factor in the development of acne lesions, and can lead to improvements in skin clarity and acne severity overall. In 90% of patients, the inflammatory lesions were observed to be decreased [21]. Oral isotretinoin is more successful than oral antibiotics in attaining durable remission after therapy, according to an assessment of the relevant research.…”

Section: Discussionmentioning

confidence: 99%

A Rare Case of Pneumomediastinum Due to Prolonged Use of N95 Facemasks During the Covıd-19 Pandemic

Assefi¹,

Jawed²

2023

J Critical Care & Emerg Med

View full text Add to dashboard Cite

Acne vulgaris is a skin condition characterized by the inflammation or hyperactivity of sebaceous glands on the skin, which results in the creation of comedones, lesions, nodules, and perifollicular hyper keratinization. Increased sebum production, follicular blockage, and bacterial colonization may contribute to the disease etiology. It primarily affects the T-zone of the face and trunk and is frequent throughout puberty. Environmental factors, hormonal imbalance, and genetic predisposition can alter the severity of disease. Its mental and monetary effects can be problematic for the society. In this study, we examined the role of isotretinoin in the treatment of acne vulgaris based on evidence from prior research. Isotretinoin has been recognized as an effective treatment for acne vulgaris, particularly in cases that have been resistant to previous medications or have resulted in scarring, according to gathered data. Oral isotretinoin inhibits the proliferation of Propionibacterium acnes, a critical factor in the development of acne lesions; also it has been shown to be effective in reducing the number of Propionibacterium-resistant patients and to regulate sebum production and reduce sebaceous gland size more effectively than other treatment options.so result in general improvements in skin clarity and acne severity and reduce inflammatory in 90% of patients. In addition to its efficacy, the majority of patients have showed that oral isotretinoin is well tolerated. Despite the fact that it is linked to a number of potential harmful effects, Skin dryness was the most common side effects reported by patients that it can be managed with the aid of suitable monitoring and administration procedures.

show abstract

Treatment of moderate to severe acne vulgaris with an oral isotretinoin similar to the reference product

Cited by 6 publications

References 25 publications

Identifying and appraising patient‐reported outcome measures on treatment satisfaction in acne: a systematic review*

Identifying and appraising patient‐reported outcome measures on treatment satisfaction in acne: a systematic review*

Uso de isotretinoína por mulheres em idade reprodutiva

A Rare Case of Pneumomediastinum Due to Prolonged Use of N95 Facemasks During the Covıd-19 Pandemic

Contact Info

Product

Resources

About