Fotobiomodulação com luz âmbar no tratamento do Melasma: ensaio clínico, randomizado, controlado, duplo cego

Detalhes bibliográficos
Ano de defesa: 2023
Autor(a) principal: Galache, Thaís Rodrigues lattes
Orientador(a): Pavani, Christiane lattes
Banca de defesa: Pavani, Christiane lattes, Cecatto, Rebeca Boltes lattes, Aveiro, Mariana Chaves lattes
Tipo de documento: Dissertação
Tipo de acesso: Acesso aberto
Idioma: por
Instituição de defesa: Universidade Nove de Julho
Programa de Pós-Graduação: Programa de Pós-Graduação em Medicina – Biofotônica
Departamento: Saúde
País: Brasil
Palavras-chave em Português:
Palavras-chave em Inglês:
Área do conhecimento CNPq:
Link de acesso: http://bibliotecatede.uninove.br/handle/tede/3772
Resumo: Introduction: Facial Melasma (FM), the main pigmentation disorder in women (90% of cases), has a partially known etiology. Tranexamic acid (ATX) treats FM by inhibiting the conversion of plasmin to plasminogen and activating autophagy. In vitro studies indicate that amber photobiomodulation (FBM) also activates autophagy. Objective: To evaluate the effect of amber FBM on FM, compared with ATX. Material and Method: This controlled, randomized, double-blind study had patients divided into 2 groups: FBM with amber LED + placebo cosmetic (Group 1) and sham FBM + 5% tranexamic acid cosmetic (Group 2). Women aged between 35 and 50 years, phototypes II to IV and who had FM were included. Participants who were using contraceptives, IUDs, hormone replacement therapy, autoimmune diseases, photosensitive medications and recent facial treatments were excluded. Participants received treatments weekly for 12 weeks and also used the product at home during this period. All participants used sunscreen provided by the researcher throughout the study. Results: 21 women aged between 39 and 49 years were included, 10 in the FBM group and 11 in the ATX group. No significant differences were found in the intragroup analysis in the MASI parameter over time for both ATX (13.8 ±2.8; 11.7 ±2.1; 11.8 ±2.2) and FBM (16.4 ±3.0; 16.8 ±2.2; 16.2 ±2.0), as well as no significant differences were found between the groups in all periods investigated. The Global Face Assessment revealed improvements in FM in both groups, with a median score of 4 [4-5] for PBM and 4 [3-4] for TXA. No significant differences were observed between the two treatments. A score of 4 represents a slight improvement, approximately 25%, with notable evidence of remaining hyperpigmentation. In the objective assessment of pigmentation intensity, no significant differences were observed in the FBM group in the intragroup comparison over the treatment time (623,658 ± 12,397; 632,800 ± 10,397; and 642,424 ± 12,134 for PBM. On the other hand, an increase was observed in the ATX group in the intensity of pigmentation at baseline in relation to the sixth week of treatment (600,325 ± 1,820; 641,088 ± 9,914; and 635,308 ± 11,569 for TXA). In the comparison between groups, no differences were found at any of the times evaluated. An improvement in quality was observed of participants' lives, as indicated by reduction in MelaQoL questionnaire scores (47.9 ± 15.6; 37.0 ± 17.0; and 19.3 ± 11.5 for PBM; 46.6 ± 12.9; 38.1 ± 9.7; and 26.8 ± 13.6 for TXA at baseline, in the sixth week and after completion of treatment, respectively). This reduction was significant after the sixth week of treatment in both groups , although no difference in quality of life was observed between the two groups. In general, only mild and transient adverse effects were found, such as erythema, flushing. Conclusion: In this pilot study, no improvement effects were found in FM throughout the treatment and follow-up based on the MASI index in any of the treatments, nor were any differences found between treatments.
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spelling Pavani, Christianehttp://lattes.cnpq.br/2148910222765744Pavani, Christianehttp://lattes.cnpq.br/2148910222765744Cecatto, Rebeca Bolteshttp://lattes.cnpq.br/0228531403374909Aveiro, Mariana Chaveshttp://lattes.cnpq.br/8912160623559438http://lattes.cnpq.br/4526743460355013Galache, Thaís Rodrigues2025-08-29T21:03:20Z2023-12-15Galache, Thaís Rodrigues. Fotobiomodulação com luz âmbar no tratamento do Melasma: ensaio clínico, randomizado, controlado, duplo cego. 2023. 86 f. Dissertação( Programa de Pós-Graduação em Medicina – Biofotônica) - Universidade Nove de Julho, São Paulo.http://bibliotecatede.uninove.br/handle/tede/3772Introduction: Facial Melasma (FM), the main pigmentation disorder in women (90% of cases), has a partially known etiology. Tranexamic acid (ATX) treats FM by inhibiting the conversion of plasmin to plasminogen and activating autophagy. In vitro studies indicate that amber photobiomodulation (FBM) also activates autophagy. Objective: To evaluate the effect of amber FBM on FM, compared with ATX. Material and Method: This controlled, randomized, double-blind study had patients divided into 2 groups: FBM with amber LED + placebo cosmetic (Group 1) and sham FBM + 5% tranexamic acid cosmetic (Group 2). Women aged between 35 and 50 years, phototypes II to IV and who had FM were included. Participants who were using contraceptives, IUDs, hormone replacement therapy, autoimmune diseases, photosensitive medications and recent facial treatments were excluded. Participants received treatments weekly for 12 weeks and also used the product at home during this period. All participants used sunscreen provided by the researcher throughout the study. Results: 21 women aged between 39 and 49 years were included, 10 in the FBM group and 11 in the ATX group. No significant differences were found in the intragroup analysis in the MASI parameter over time for both ATX (13.8 ±2.8; 11.7 ±2.1; 11.8 ±2.2) and FBM (16.4 ±3.0; 16.8 ±2.2; 16.2 ±2.0), as well as no significant differences were found between the groups in all periods investigated. The Global Face Assessment revealed improvements in FM in both groups, with a median score of 4 [4-5] for PBM and 4 [3-4] for TXA. No significant differences were observed between the two treatments. A score of 4 represents a slight improvement, approximately 25%, with notable evidence of remaining hyperpigmentation. In the objective assessment of pigmentation intensity, no significant differences were observed in the FBM group in the intragroup comparison over the treatment time (623,658 ± 12,397; 632,800 ± 10,397; and 642,424 ± 12,134 for PBM. On the other hand, an increase was observed in the ATX group in the intensity of pigmentation at baseline in relation to the sixth week of treatment (600,325 ± 1,820; 641,088 ± 9,914; and 635,308 ± 11,569 for TXA). In the comparison between groups, no differences were found at any of the times evaluated. An improvement in quality was observed of participants' lives, as indicated by reduction in MelaQoL questionnaire scores (47.9 ± 15.6; 37.0 ± 17.0; and 19.3 ± 11.5 for PBM; 46.6 ± 12.9; 38.1 ± 9.7; and 26.8 ± 13.6 for TXA at baseline, in the sixth week and after completion of treatment, respectively). This reduction was significant after the sixth week of treatment in both groups , although no difference in quality of life was observed between the two groups. In general, only mild and transient adverse effects were found, such as erythema, flushing. Conclusion: In this pilot study, no improvement effects were found in FM throughout the treatment and follow-up based on the MASI index in any of the treatments, nor were any differences found between treatments.Introdução: O melasma facial (MF), principal distúrbio de pigmentação em mulheres (90% dos casos), tem etiologia parcialmente conhecida. O Ácido tranexâmico (ATX) trata o MF inibindo a conversão da plasmina em plasminogênio e ativando a autofagia. Estudos in vitro indicam que a fotobiomodulação (FBM) âmbar também ativa a autofagia. Objetivo: Avaliar o efeito da FBM âmbar no MF, em comparação com ATX. Material e Método: Este estudo controlado, randomizado e duplo-cego teve pacientes divididos em 2 grupos: FBM com Led âmbar + cosmético placebo (Grupo 1) e FBM sham + cosmético ácido tranexâmico 5% (Grupo 2). Foram incluídas mulheres com idades entre 35 a 50 anos, fototipos II a IV e que apresentavam MF. Foram excluídas participantes que faziam uso de contraceptivos, DIU, reposição hormonal, doenças autoimunes, medicamentos fotossensíveis e tratamentos faciais recentes. Os participantes receberam os tratamentos semanalmente, por 12 semanas e também fizeram o uso domiciliar do produto durante este período. Todos os participantes utilizaram protetor solar fornecido pelo pesquisador, durante todo o estudo. Resultados: 21 mulheres com idade entre 39 e 49 anos foram incluídas, sendo 10 no grupo FBM e 11 no grupo ATX. Não foram encontradas diferenças significantes na análise intragrupo no parâmetro MASI ao longo do tempo para ambos tratamentos ATX (13,8 ±2,8; 11,7 ±2,1; 11,8 ±2,2) e FBM (16,4 ±3,0; 16,8 ±2,2; 16,2 ±2,0), bem como não foram encontradas diferenças significantes entre os grupos em todos os períodos investigados. A Avaliação Global da Face revelou melhorias no MF em ambos os grupos, com uma pontuação mediana de 4 [4-5] para PBM e 4 [3-4] para TXA. Não foram observadas diferenças significativas entre os dois tratamentos. Uma pontuação de 4 representa uma ligeira melhoria, aproximadamente 25%, com evidência notável de hiperpigmentação remanescente. Na avaliação objetiva da intensidade da pigmentação não foram observadas diferenças significantes no grupo FBM na comparação intragrupo ao longo do tempo de tratamento (623.658 ± 12.397; 632.800 ± 10.397; e 642.424 ± 12.134 para PBM. Por outro lado, no grupo ATX foi observado aumento na intensidade de pigmentação do baseline em relação à sexta semana de tratamento (600.325 ± 1.820; 641.088 ± 9.914; e 635.308 ± 11.569 para TXA). Na comparação entre grupos, não foram encontradas diferenças em nenhum dos tempos avaliados. Foi observada melhora na qualidade de vida dos participantes, conforme indicado por redução nas pontuações do questionário MelaQoL (47,9 ± 15,6; 37,0 ± 17,0; e 19,3 ± 11,5 para PBM; 46,6 ± 12,9; 38,1 ± 9,7; e 26,8 ± 13,6 para TXA no início do estudo, na sexta semana e após a conclusão do tratamento, respectivamente). Esta redução foi significativa após a sexta semana de tratamento em ambos os grupos, embora não tenha sido observada diferença na qualidade de vida entre os dois grupos. De maneira geral foram encontrados somente efeitos adversos leves e transitórios como eritema, rubor. Conclusão: Neste estudo piloto não foram encontrados efeitos de melhora no MF ao longo do tratamento e follow up 10 com base no índice MASI em nenhum dos tratamentos bem como não foram encontradas diferenças entre os tratamentos.Submitted by Nadir Basilio (nadirsb@uninove.br) on 2025-08-29T21:03:20Z No. of bitstreams: 1 Thais Rodrigues Galache.pdf: 8026849 bytes, checksum: 575c8eaae16260f4e40f3b7d6603c279 (MD5)Made available in DSpace on 2025-08-29T21:03:20Z (GMT). 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dc.title.por.fl_str_mv Fotobiomodulação com luz âmbar no tratamento do Melasma: ensaio clínico, randomizado, controlado, duplo cego
dc.title.alternative.eng.fl_str_mv Amber photobiomodulation for the treatment of Melasma: double-blind, randomised, controlled trial
title Fotobiomodulação com luz âmbar no tratamento do Melasma: ensaio clínico, randomizado, controlado, duplo cego
spellingShingle Fotobiomodulação com luz âmbar no tratamento do Melasma: ensaio clínico, randomizado, controlado, duplo cego
Galache, Thaís Rodrigues
Melasma
fotobiomodulação
ácido tranexâmico
LED ambar
LLLT
Melasma
photobiomodulation
tranexamic acid
amber LED
LLLT
CIENCIAS DA SAUDE
title_short Fotobiomodulação com luz âmbar no tratamento do Melasma: ensaio clínico, randomizado, controlado, duplo cego
title_full Fotobiomodulação com luz âmbar no tratamento do Melasma: ensaio clínico, randomizado, controlado, duplo cego
title_fullStr Fotobiomodulação com luz âmbar no tratamento do Melasma: ensaio clínico, randomizado, controlado, duplo cego
title_full_unstemmed Fotobiomodulação com luz âmbar no tratamento do Melasma: ensaio clínico, randomizado, controlado, duplo cego
title_sort Fotobiomodulação com luz âmbar no tratamento do Melasma: ensaio clínico, randomizado, controlado, duplo cego
author Galache, Thaís Rodrigues
author_facet Galache, Thaís Rodrigues
author_role author
dc.contributor.advisor1.fl_str_mv Pavani, Christiane
dc.contributor.advisor1Lattes.fl_str_mv http://lattes.cnpq.br/2148910222765744
dc.contributor.referee1.fl_str_mv Pavani, Christiane
dc.contributor.referee1Lattes.fl_str_mv http://lattes.cnpq.br/2148910222765744
dc.contributor.referee2.fl_str_mv Cecatto, Rebeca Boltes
dc.contributor.referee2Lattes.fl_str_mv http://lattes.cnpq.br/0228531403374909
dc.contributor.referee3.fl_str_mv Aveiro, Mariana Chaves
dc.contributor.referee3Lattes.fl_str_mv http://lattes.cnpq.br/8912160623559438
dc.contributor.authorLattes.fl_str_mv http://lattes.cnpq.br/4526743460355013
dc.contributor.author.fl_str_mv Galache, Thaís Rodrigues
contributor_str_mv Pavani, Christiane
Pavani, Christiane
Cecatto, Rebeca Boltes
Aveiro, Mariana Chaves
dc.subject.por.fl_str_mv Melasma
fotobiomodulação
ácido tranexâmico
LED ambar
LLLT
topic Melasma
fotobiomodulação
ácido tranexâmico
LED ambar
LLLT
Melasma
photobiomodulation
tranexamic acid
amber LED
LLLT
CIENCIAS DA SAUDE
dc.subject.eng.fl_str_mv Melasma
photobiomodulation
tranexamic acid
amber LED
LLLT
dc.subject.cnpq.fl_str_mv CIENCIAS DA SAUDE
description Introduction: Facial Melasma (FM), the main pigmentation disorder in women (90% of cases), has a partially known etiology. Tranexamic acid (ATX) treats FM by inhibiting the conversion of plasmin to plasminogen and activating autophagy. In vitro studies indicate that amber photobiomodulation (FBM) also activates autophagy. Objective: To evaluate the effect of amber FBM on FM, compared with ATX. Material and Method: This controlled, randomized, double-blind study had patients divided into 2 groups: FBM with amber LED + placebo cosmetic (Group 1) and sham FBM + 5% tranexamic acid cosmetic (Group 2). Women aged between 35 and 50 years, phototypes II to IV and who had FM were included. Participants who were using contraceptives, IUDs, hormone replacement therapy, autoimmune diseases, photosensitive medications and recent facial treatments were excluded. Participants received treatments weekly for 12 weeks and also used the product at home during this period. All participants used sunscreen provided by the researcher throughout the study. Results: 21 women aged between 39 and 49 years were included, 10 in the FBM group and 11 in the ATX group. No significant differences were found in the intragroup analysis in the MASI parameter over time for both ATX (13.8 ±2.8; 11.7 ±2.1; 11.8 ±2.2) and FBM (16.4 ±3.0; 16.8 ±2.2; 16.2 ±2.0), as well as no significant differences were found between the groups in all periods investigated. The Global Face Assessment revealed improvements in FM in both groups, with a median score of 4 [4-5] for PBM and 4 [3-4] for TXA. No significant differences were observed between the two treatments. A score of 4 represents a slight improvement, approximately 25%, with notable evidence of remaining hyperpigmentation. In the objective assessment of pigmentation intensity, no significant differences were observed in the FBM group in the intragroup comparison over the treatment time (623,658 ± 12,397; 632,800 ± 10,397; and 642,424 ± 12,134 for PBM. On the other hand, an increase was observed in the ATX group in the intensity of pigmentation at baseline in relation to the sixth week of treatment (600,325 ± 1,820; 641,088 ± 9,914; and 635,308 ± 11,569 for TXA). In the comparison between groups, no differences were found at any of the times evaluated. An improvement in quality was observed of participants' lives, as indicated by reduction in MelaQoL questionnaire scores (47.9 ± 15.6; 37.0 ± 17.0; and 19.3 ± 11.5 for PBM; 46.6 ± 12.9; 38.1 ± 9.7; and 26.8 ± 13.6 for TXA at baseline, in the sixth week and after completion of treatment, respectively). This reduction was significant after the sixth week of treatment in both groups , although no difference in quality of life was observed between the two groups. In general, only mild and transient adverse effects were found, such as erythema, flushing. Conclusion: In this pilot study, no improvement effects were found in FM throughout the treatment and follow-up based on the MASI index in any of the treatments, nor were any differences found between treatments.
publishDate 2023
dc.date.issued.fl_str_mv 2023-12-15
dc.date.accessioned.fl_str_mv 2025-08-29T21:03:20Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/masterThesis
format masterThesis
status_str publishedVersion
dc.identifier.citation.fl_str_mv Galache, Thaís Rodrigues. Fotobiomodulação com luz âmbar no tratamento do Melasma: ensaio clínico, randomizado, controlado, duplo cego. 2023. 86 f. Dissertação( Programa de Pós-Graduação em Medicina – Biofotônica) - Universidade Nove de Julho, São Paulo.
dc.identifier.uri.fl_str_mv http://bibliotecatede.uninove.br/handle/tede/3772
identifier_str_mv Galache, Thaís Rodrigues. Fotobiomodulação com luz âmbar no tratamento do Melasma: ensaio clínico, randomizado, controlado, duplo cego. 2023. 86 f. Dissertação( Programa de Pós-Graduação em Medicina – Biofotônica) - Universidade Nove de Julho, São Paulo.
url http://bibliotecatede.uninove.br/handle/tede/3772
dc.language.iso.fl_str_mv por
language por
dc.relation.cnpq.fl_str_mv 8765449414823306929
dc.relation.confidence.fl_str_mv 600
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Universidade Nove de Julho
dc.publisher.program.fl_str_mv Programa de Pós-Graduação em Medicina – Biofotônica
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