- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07637032
Clinical Study of a Facial Cream for Rosacea
Visão geral do estudo
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Yanwen Jiang
- Número de telefone: 13501700841
- E-mail: jiangyanwen@china-norm.com
Locais de estudo
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Shanghai, China
- Recrutamento
- Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072, Shanghai,
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Contato:
- Yanwen Jiang
- Número de telefone: +86 13501700841
- E-mail: jiangyanwen@china-norm.com
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Female Chinese subjects aged 20 to 50 years with Fitzpatrick skin type III-IV;
- In good general health, with no chronic diseases or illnesses under treatment;
- Assessed by a dermatologist at the baseline visit:
(1)Present with persistent mild erythema on the midface (cheeks, nose, chin and forehead), graded as mild to moderate with a score of 2-3 according to the Clinician's Erythema Assessment (CEA, 0-4 scale) for facial persistent erythema; (2)Graded as mild to moderate with a score of 2-3 based on the papule and pustule assessment scale, inflammatory lesion count and Investigator's Global Assessment (IGA, 0-4 scale); (3)5Have no more than 3 mild inflammatory papules/pustules on the face; Present with none or only very mild facial telangiectasia; (4)Have not changed daily skin care products in the past three months, and do not use soothing skin care products, medical devices or medical dressings. 4.No additional or replacement skin care products are permitted throughout the study period except the test product.
5.The participants voluntarily join the study, fully understand the trial content and are willing to sign the informed consent form and portrait use authorization.
6.During the entire study period, participants shall comply with the study protocol, use the products provided by the study, and refrain from using other similar products. They are also required to keep study diaries and attend regular follow-up visits as stipulated.
Exclusion Criteria:
- Female participants who are planning to become pregnant, are pregnant or breastfeeding, are within 6 months post-delivery, or refuse to take adequate contraceptive precautions.
- Participants currently enrolled in another clinical trial, or who have participated in any other clinical trial within the preceding 3 months.
- Participants who have received physical, chemical or cosmetic procedures within 3 months prior to study enrollment.
- Participants who have used any medications for rosacea within 4 weeks prior to enrollment, including topical preparations (metronidazole, azelaic acid, erythromycin ointment, etc.), oral agents (minocycline, doxycycline, oral isotretinoin, etc.) or corticosteroids (e.g., hydrocortisone).
- Participants with systemic diseases complicated by severe organ damage, cardiovascular diseases, hepatic or renal dysfunction, malignant tumors, poorly controlled chronic diseases, acute infectious diseases, major surgery or trauma, psychiatric disorders; or those requiring topical or systemic medications/treatments that may affect atopic dermatitis for other medical conditions.
- Participants with other dermatoses (atopic dermatitis, seborrheic dermatitis, eczema, etc.) or evaluative confounding skin conditions (birthmarks, scars, etc.) at the study site.
- Participants presenting with symptoms of phymatous rosacea or ocular rosacea at the study site.
- Participants with a history of allergic contact dermatitis induced by cleansers or moisturizers.
- Participants with a history of allergy to the investigational product or its ingredients, or a history of severe allergic reactions.
- Participants who fail to meet compliance requirements, are unable to attend scheduled visits on time, or are unwilling to abide by the study protocol throughout the trial.
- Any other conditions that, in the investigator's opinion, make the individual unsuitable for study participation.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Arm 1
Investigational test cream, designed to evaluate its soothing effect on skin.
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Morning/Evening: Study participants shall cleanse their entire face with water or facial cleanser.
After the skin is dry, apply an appropriate amount of the investigational product cream (1-2 pumps per use) to the entire face and gently massage until absorbed.
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Experimental: Arm 2
Subjects' own non-soothing daily facial cream, used as a negative control.
No study-specific active intervention is provided in this arm.
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Morning/Evening: Study participants shall cleanse their entire face with water or facial cleanser.
After the skin is dry, apply an appropriate amount of the participants' usual non-soothing facial cream (per their regular daily usage) to the entire face and gently massage until absorbed.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Dermatologist-Assessed Rosacea Severity
Prazo: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
|
Investigator's Global Assessment (IGA) is a clinical tool that can be used to evaluate the severity of rosacea.
The severity of rosacea is assessed and determined using the IGA grading scale, with scores recorded at T0 (baseline), T2w (2 weeks), T4w (4 weeks), and T8w (8 weeks).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Dermatologist assessment of persistent erythema
Prazo: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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The Persistent Erythema CEA Scale (0-4 points) is used to assess persistent erythema.
Scoring will be performed at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Dermatologist assessment of Counting Inflammatory Lesions
Prazo: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Dermatologists will count facial papules and pustules of study participants at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Clinical assessment of facial TRoSA telangiectasia counts in subjects by dermatologists
Prazo: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Assessment of subjects' telangiectasia is conducted using the TRoSA Telangiectasia Scale (0-4 points).
Scoring is performed at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Dermatologist assessment of product tolerability
Prazo: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Dermatologists use the safety assessment scale (0-3 points) to evaluate symptoms including edema, papules, desquamation, stinging, pruritus and burning.
Assessments are performed at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Self-assessment Questionnaire
Prazo: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Study participants are required to complete the skin sensation self-assessment questionnaire (Likert scale) and the Dermatology Life Quality Index (DLQI) at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Change in Skin Hydration Measured by Corneometer
Prazo: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Change in Transepidermal Water Loss (TEWL) measured by Tewameter® TM HEX (Courage + Khazaka, Germany)
Prazo: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Change in Hemoglobin Index measured by Mexameter® MX 18 (Courage + Khazaka, Germany)
Prazo: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Skin changes captured via VISIA-CR imaging (Canfield Scientific, Inc., USA)
Prazo: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- C26036010
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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