Sunscreen Efficacy Against the Reccurence of Lesions Post-sun Exposure in Acneic Subjects
7 de diciembre de 2021 actualizado 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.
Descripción general del estudio
Descripción detallada
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 estudio
De observación
Inscripción (Actual)
45
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Lisboa, Portugal, 1750-182
- PhD Trials®
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
12 años a 40 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
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
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Assessment of the dermatological physical signs
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Change from Baseline to 29 days later
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Change from Baseline to 29 days later
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change of the number of total acne lesions on the face
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Pedro Contreiras Pinto, PhD, PhD Trials®
- Investigador principal: Leonor Girão, MD, PhD Trials®
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
16 de julio de 2020
Finalización primaria (Actual)
9 de noviembre de 2020
Finalización del estudio (Actual)
9 de noviembre de 2020
Fechas de registro del estudio
Enviado por primera vez
29 de septiembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
7 de diciembre de 2021
Publicado por primera vez (Actual)
23 de diciembre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de diciembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
7 de diciembre de 2021
Última verificación
1 de diciembre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- RV4857A202092
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .