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Effects of Camouflage on the Life Quality of Patients With Vitiligo

17 de maio de 2018 atualizado por: Xijing Hospital

Development and Psychometric Validation of the Chinese Version of Vitiligo Life Quality Index and Effects of Camouflage on the Life Quality of Patients With Vitiligo: A Randomized Open-label Controlled Study

Vitiligo is a common depigmented skin disease characterized by destruction of functional melanocyte.The recent therapies to vitiligo are including oral or external glucocorticoids, antioxidants, calcineurin inhibitors or phototherapy. However, long treatment period and unsatisfactory curative effects still exist, which confer long-term psychological burden to patients. As above concerns, it is of great value to explore therapeutic methods that can effectively control disease, improve appearance, relieve patients' pain and improve their quality of life. Current problem is the lack of a vitiligo life quality evaluation scale with Chinese characteristics for us. Therefore, it is necessary for the investigator to compile a vitiligo quality of life scale that is simple, feasible and applicable to China's national conditions. Meanwhile the reliability analysis must be carried out to bring better quality of life assessment tools to patients with vitiligo in China. Previous studies recommended that CapulinTM showing a good cover effect on vitiligo, but the effects of camouflage on the QoL of patients with vitiligo in Chinese population is unknown. Thus, the investigators undergo a randomized open-label controlled study to estimate the effects of CapulinTM on QoL of patients with vitiligo.

Visão geral do estudo

Descrição detalhada

Vitiligo is a common depigmented skin disease characterized by destruction of functional melanocyte. The global incidence is about 0.5-2.0% and prevalence be about 0.8-1.5% in China. Studies showed that almost half of vitiligo patients had developed depigmentation before 20 years old. Lesions involving exposed skin such as face, hand or mucous always make patients feeling embarrassment, so the impaired quality of life (QoL) have greater impact on patients with vitiligo than the disease itself. Besides, Vitiligo is also a psychosomatic disease as its cause stress or depression which can induce dysfunction of endocrine system or immune system in patients, finally resulted in poor curative effects and relapse of the disease which further aggravates stress and depression in patients. Furthermore, traditional Chinese medicine suggested that uneasiness would be a cause of vitiligo as well.

It is of great value to explore therapeutic methods that can effectively control disease, improve appearance, relieve patients' pain and improve their quality of life. Dermatologists of Japan and European suggested that camouflage would be a proper way to improve patients' appearance and it should be an effective supplement to the treatments of vitiligo.

With the transformation of the medical model from a simple biomedical model to a bio-psychological-social medical model, observing changes of lesion in vitiligo may not fully reflect the impact of vitiligo on patients. Therefore, it is necessary to develop some evaluation methods to reflect the impact of vitiligo in patients. Among the various measurement tools, universality scales have a wide range of measurement and can be applied to different groups of people to understand the general health status of the general population. But there are some limitations due to the unspecifically designed for a disease group. When the universal scale is applied to a specific disease, it does not have specificity. Some clinically significant information on quality of life may be omitted, and the QOL cannot be sensitively reflected. The scales in the dermatology area were developed for patients with dermatological diseases and reflect the differences between skin diseases and other system diseases. However, the specificity and sensitivity of specific diseases are still not strong enough.The problem is the lack of a vitiligo life quality evaluation scale with Chinese characteristics for us. Therefore, it is necessary for the investigator to compile a vitiligo quality of life scale that is simple, feasible and applicable to China's national conditions. Meanwhile the reliability analysis must be carried out to bring better quality of life assessment tools to patients with vitiligo in China.

Camouflage is an emerging solution to improve patients' appearance which showing a great potential in treatment of vitiligo. Diagnosis and treatment of vitiligo consensus (2014 edition) made by the dermatological department of the Chinese medical association also suggest that camouflage can be used on exposed skin such as face, neck, hands or feet.The first commercial camouflage agent in China is CapulinTM by 2004, Its formula contains natural plant extracts, moisturizers, emollients and natural pigments. The regimented mechanism is to combine the camouflage with the free protein on the cuticle and finally format the mimic human natural melanin, which is extremely similar to normal skin tone. Previous studies recommended that CapulinTM showing a good cover effect on vitiligo, but the effects of camouflage on the QoL of patients with vitiligo in Chinese population is unknown. Thus, the investigators undergo a randomized open-label controlled study to estimate the effects of CapulinTM on QoL of patients with vitiligo.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

400

Estágio

  • Fase inicial 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recrutamento
        • Xijing Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 64 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Subjects who signed Informed Consent Form;
  • Male or female subjects 18-64 years of age;
  • Clinically confirmed diagnosis of vitiligo as per the diagnostic criteria for vitiligo specified in Clinical Dermatology.

Exclusion Criteria:

  • Incompliance with the diagnosis of vitiligo.
  • Patients who had used other camouflage before;
  • Cannot read or understand questionnaire.
  • Patients who had taken antidepressants in the last three months had psychiatric and psycho-related illnesses.;
  • Inability to guarantee taking medications and completing visits as scheduled during the study;
  • Allergic history of any relevant ingredient in the camouflage;
  • The combination of eczema, contact dermatitis, urticaria and other allergic diseases or other serious diseases which are not suitable for the treatment of skin diseases;
  • Serious life-threatening condition such as cancer, autoimmune diseases;
  • Women of child-bearing potential who are pregnant, plan to become pregnant during study or are lactating;
  • Participating in other clinical studies or within 3 months;
  • Any other condition that the investigator deems unsuitable for entering the study.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Group A
complete Chinese version of the vitiligo life quality index, VLQI-C, conventional therapies plus CapulinTM on-demand treatment period
a kind of camouflage agent
a questionaire designed for patients with vitiligo
Comparador de Placebo: Group B
complete Chinese version of the vitiligo life quality index, VLQI-C, conventional therapies on-demand treatment period
a questionaire designed for patients with vitiligo

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Chinese version of the vitiligo life quality index, VLQI-C
Prazo: 4 weeks
Chinese version of the vitiligo life quality index, VLQI-C
4 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
VASI Scoring Criteria
Prazo: 4 weeks
VASI=Σall body sites (hand units) × depigmentation
4 weeks
Vitiligo European Task Force assessment, VETFa
Prazo: 4 weeks
Vitiligo European Task Force assessment, VETFa
4 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Chunying Li, Principal Investigator

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de janeiro de 2018

Conclusão Primária (Antecipado)

1 de janeiro de 2019

Conclusão do estudo (Antecipado)

1 de janeiro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

4 de maio de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de maio de 2018

Primeira postagem (Real)

30 de maio de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de maio de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de maio de 2018

Última verificação

1 de março de 2018

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • XJPF-LCY-V201804

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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