Sunscreen Efficacy Against the Reccurence of Lesions Post-sun Exposure in Acneic Subjects
7 de dezembro de 2021 atualizado por: Pierre Fabre Dermo Cosmetique
Evaluation of the Cutaneous and Ocular Tolerance of RV4857A Sunscreen Product and Its Efficacy Against the Recurrence of Lesions Post Sun Exposure in Subjects With Facial Acne
The aim of this study is firstly to assess the tolerance of the sunscreen RV4857A-CD2110 after 28 days and 57 days of at least a twice daily on the study areas, secondly to assess anti-imperfection efficacy after 28 days and 57 days of use and its efficacy against recurrence of acne lesions post-sun exposure.
Visão geral do estudo
Descrição detalhada
This is a monocentric study on adults and adolescents with acne prone skin on the face. This open-labelled study aim first to assess the dermatological and ophthalmological tolerance of the investigational sunscreen product RV4857A formula CD2110 after 28 days and, dermatological tolerance after 57 days of at least a twice daily on the study areas, under normal conditions of use, on 40 subjects intending to have a minimum of 10 days per month of sun exposure duration ≥ 1h, in the time slot 11am-4pm and intending to have a minimum of 4 swimming sessions (sea or swimming pool) during at least the first month of the study.
Secondary objectives :
- To assess the anti-imperfection efficacy of the product during the summer
- To assess the "non" rebound effect (non recurrence of acne) one month after stopping the application of the sunscreen and without any sun exposure at D85 (difference between D85 and D0)
- To evaluate the impact on Quality of Life of subjects through CADI and DLQI questionnaires (or CDLQI questionnaire for adolescent from 12 to 16 years-old) completed at baseline, D29 and D57
The study includes 4 visits :
- Visit 1: Inclusion visit (D1)
- Visit 2: Intermediate visit (D29)
- Visit 3: Intermediate visit "end of summer" (D57), a Stop the application of the sunscreen product (and stop sun exposure) between Visit 3 and the end of the study Visit 4: End of study visit in autumn (D85)
The theoretical study duration for each subject will be 85 days with at least 57 days of product use. The study interest areas are Face and Neck.
Tipo de estudo
Observacional
Inscrição (Real)
45
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
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Lisboa, Portugal, 1750-182
- PhD Trials®
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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
12 anos a 40 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
Subjects will be recruited from the investigation centre's panel.
The participants will be selected on the basis of inclusion and non-inclusion criteria specific to the study and on their ability to comply with the constraints required by the protocol.
The participants will be definitely included in the study after a specific interview and a clinical examination
Descrição
Inclusion Criteria:
Related to the population:
- Females and/or males (with at least 25% of male)
- Age: adults from 18 to 40 years old and adolescent from 12 to 17 years old (33% to 50% of the total population)
- Considered "healthy subject" by the Investigator
- Being of Phototype I to IV
- Subject with combination to oily skin
- Subject who foresees sun exposure during the first 2 months of the study
- Subjects must be registered with health social security or health social insurance (if required by national regulations)
- Subject and/or parent(s)/legal representative(s) who have signed his/her/their written informed consent for his/her participation in the study (or his/her/their child participation in the study) and a photograph authorization
- For woman of childbearing potential: committing herself to use effective contraceptive method since at least 3 months before the beginning of the study and committing to it throughout the study
- Regular users of very high protection sunscreen products.
Related to the disease:
- For adults and adolescents: subject with mild to moderate acne with a total of 10 to 40 acne lesions (at least 5 non-inflammatory lesions (open and closed comedones) and at least 3 to 10 inflammatory lesions (papules and pustules) maximum on the face, excluding the nose area), at the inclusion.
- Subject prone to have recurrence of acne lesions in autumn (declarative)
Exclusion Criteria:
Related to the population:
- Having participated in another clinical trial within 4 weeks before the inclusion visit and for a longer period if required in the Investigator's opinion Taking part or planning to participate in another clinical trial during the study in the same or another investigation centre
- Breastfeeding or pregnant or not willing to take necessary precautions to avoid pregnancy during the study and for at least 3 months before the inclusion visit (for the woman of childbearing potential)
- Subject or parent(s)/legal representative(s) deprived of freedom by administrative or legal decision or under guardianship
- Subject or parent(s)/legal representative(s) not able to be contacted in case of emergency
- Subject admitted in a sanitary or social facility
- Subject planning a hospitalization during the study
Related to the disease
- Cutaneous pathology (psoriasis, atopic dermatitis, skin infectious disease of viral, bacterial, fungus or parasitic origin …) or dermatological condition (especially pityriasis versicolor, severe pigmentation disorders) on the studied zone other than acne liable to interfere with the data of the study
- Severe acne
- Clinical signs of hormonal disfunctions or hyperandrogenism
- Excessive exposure to sunlight or UV-rays within the previous month
- Having history of abnormal reactions from exposure to sunlight
- Use of self tanning product during the previous month History of hypersensitivity or intolerance to any cosmetic product
Related to treatments
- Use of a systemic or topical medication with anti-inflammatory or photosensitising products during the previous 2 weeks and for systemic medication with corticoids and/or antihistaminics during the previous 4 weeks
- Use of a systemic treatment for acne during the previous month for antibiotics, zinc gluconate and hormonal treatment and during the 6 previous months for isotretinoin
- Use of a topical treatment for acne during the previous month (benzoil peroxide, retinoid, antibiotics, azelaic acid…)
- Use of anti-acneic or anti-seborrheic cosmestic care (containing alpha hydroxy-acids, retinoic derivatives..) during the 15 previous days
- Use of other topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous tolerance and efficacy of the studied product (according to the investigator's appreciation)
- Any surgery, chemical or physical treatment on the experimental area within the 12 months prior to the study or foreseeing it for the duration of the study
- Woman whose oral contraception is instaured or changed for less than 3 months
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
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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RV4857A arm
Application of the product before and during each sun exposure, at least twice a day. During sun exposures, the applications were renewed as often as necessary, in particular after swimming, perspiring, towelling, in order to ensure a good protection. On days of bad weather, the product was applied in the morning and at the beginning of the afternoon. |
RV4857A formula CD2110 is a sunscreen product
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Assessment of the dermatological physical signs
Prazo: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
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The assessment of the dermatological physical signs is based on a visual examination
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Change from Baseline to 30 minutes after product application, to 29 and 57 days later
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Assessment of the dermatological functional signs
Prazo: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
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The functional signs is assessed by questioning the subject
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Change from Baseline to 30 minutes after product application, to 29 and 57 days later
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Assessment of the ophthalmological physical signs
Prazo: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
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The assessment of the ophthalmological physical signs is based on a dermatologist visual examination
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Change from Baseline to 30 minutes after product application, to 29 and 57 days later
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Assessment of the ophthalmological functional signs
Prazo: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
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The functional signs is assessed by questioning the subject
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Change from Baseline to 30 minutes after product application, to 29 and 57 days later
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Assessment of the Tear film Break Up Time (BUT)
Prazo: Change from Baseline to 30 minutes after product application, to 29 and 57 days later
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The tear film break-up time is a test to measure the relative stability of the pre-corneal tear film.
This examination is performed by the same Ophthalmologist thanks to a biomicroscope after blinking (using a chronometer).
The measured time will be expressed in seconds
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Change from Baseline to 30 minutes after product application, to 29 and 57 days later
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Assessment of global tolerance assessment (dermatogical assesment), a 5-point scale
Prazo: Change from Baseline to 29 and 57 days later
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Change from Baseline to 29 and 57 days later
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Assessment of global tolerance assessment (ophthalmological assessment), a 5-point scale
Prazo: Change from Baseline to 29 days later
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Change from Baseline to 29 days later
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change of the number of total acne lesions on the face
Prazo: Change from Baseline to 29, 57 and 85 days later
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by counting according to the method of Lucky
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Change from Baseline to 29, 57 and 85 days later
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Change of the number of non-inflammatory lesions (open and closed comedones) on the face
Prazo: Change from Baseline to 29, 57 and 85 days later
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by counting according to the method of Lucky
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Change from Baseline to 29, 57 and 85 days later
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Change of the number of inflammatory lesions (papules, pustules, nodules) on the face
Prazo: Change from Baseline to 29, 57 and 85 days later
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by counting according to the method of Lucky
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Change from Baseline to 29, 57 and 85 days later
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Assessment of the non-comedogenic potential
Prazo: Change from Baseline to 29 days later
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by statistical comparison of open and closed comedones counted by the investigator on the face before and after 28 days of application of investigational product
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Change from Baseline to 29 days later
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Change of the acne severity, assess by Global Acne Evaluation (GEA) on a 6-point scale
Prazo: Change from Baseline to 29, 57 and 85 days later
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Change from Baseline to 29, 57 and 85 days later
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Evaluation of the global acne evolution on a 6-point scale
Prazo: Change from Baseline to 29 and 57 days later
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-1: Worsening, 0: No change,
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Change from Baseline to 29 and 57 days later
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Evaluation of the global product efficacy by the subjects themselves regarding rebound effect in Autumn
Prazo: Change from Baseline to 85 days later
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Questions Q24 and Q25 at D85 in the self-questionnaire
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Change from Baseline to 85 days later
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Assessment of the cosmetic acceptability and perceived efficacy of the product
Prazo: Change from Baseline to 29 and 57 days later
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The self subject assemsment consists of different questions concerning participants' perception of the product's efficacy (majority of scales ranging from 0 to 10 where 0 was the worst satisfaction and 10 the best one)
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Change from Baseline to 29 and 57 days later
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To evaluate the impact on Quality of Life of subjects through questionnaires
Prazo: Change from Baseline to 29 and 57 days later
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Quality of Life questionnaires consist of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week
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Change from Baseline to 29 and 57 days later
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Cadeira de estudo: Pedro Contreiras Pinto, PhD, PhD Trials®
- Investigador principal: Leonor Girão, MD, PhD Trials®
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)
16 de julho de 2020
Conclusão Primária (Real)
9 de novembro de 2020
Conclusão do estudo (Real)
9 de novembro de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
29 de setembro de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de dezembro de 2021
Primeira postagem (Real)
23 de dezembro de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
23 de dezembro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de dezembro de 2021
Última verificação
1 de dezembro de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- RV4857A202092
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
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .