Clinical Evaluation of an Atopic Skin Product Containing Picea Abies Resin Extract
4 de maio de 2026 atualizado por: Repolar Pharmaceuticals Oy
Clinical-Instrumental Evaluation of the Efficacy of Two Cosmetic Products in Comparison: Placebo Controlled Study
This study evaluates the repairing efficacy of a cosmetic cream containing Picea abies extract compared to a placebo (cream without extract) and a benchmark product. The trial involves 60 healthy subjects (aged 18-60) with atopy-prone and sensitive skin.
Over a 21-day period, the primary objective is to measure improvements in skin barrier function via transepidermal water loss (TEWL) and skin moisturization. A dermatologist will also assess soothing effects by evaluating skin dryness, redness, and itching sensations. Secondary objectives include measuring skin inflammation markers (TNFα, TSLP, and TARC) and subject-perceived efficacy through self-assessment questionnaires.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
This is a multi-site, randomized, placebo-controlled, and benchmark-controlled clinical trial designed to evaluate the repairing and soothing efficacy of a cosmetic cream containing Picea abies extract. The study is conducted on 60 healthy male and female subjects (66 enrolled to account for a 10% dropout rate) aged 18 to 60 years who exhibit atopy-prone and sensitive skin.
Subjects are randomized into three parallel groups (N=20 per group):
Test Product: Atopic cream with Picea abies extract.
Placebo: Atopic cream without Picea abies extract.
Benchmark: A commercially available reference cream.
The intervention consists of applying the assigned product twice daily to clean, dry skin on the face and body for a duration of 21 days.
Clinical and instrumental evaluations are performed at baseline (T0) and after 21 days (T21). Instrumental assessments include the measurement of Transepidermal Water Loss (TEWL) and skin moisturization levels. Clinical evaluations are conducted by a dermatologist to assess physical signs (dryness, desquamation, redness) and functional signs (stinging, itching, burning, and tightness). Additionally, skin inflammation markers (TNFα, TSLP, and TARC) are dosed to evaluate the biological effect on skin barrier inflammation. Subjective efficacy is captured through a standardized self-assessment questionnaire.
Tipo de estudo
Intervencional
Inscrição (Real)
66
Estágio
- Não aplicável
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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Pavia
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San Martino Siccomario, Pavia, Itália, 27028
- Complife Italia S.r.l
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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
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Healthy male and female subjects aged 18 to 60 years.
- Caucasian ethnicity.
- Subjects with atopy-prone skin on cheekbones and forearms, characterized by sensitive/reactive skin, redness, or itching.
- Transepidermal water loss (TEWL) thresholds at screening: Cheekbones ≥ 20 g/m^2/h and Forearms ≥10 g/m^2/h.
- Stable pharmacological therapy for at least one month without planned changes.
- Subjects aware of study procedures and having signed an informed consent form.
Exclusion Criteria:
- Acute or chronic diseases liable to interfere with study data or subject safety.
- Participation in other clinical trials or insufficient washout period (14 days).
- Known hypersensitivity or allergy to any ingredients in the test products.
- Use of pharmacological treatments considered incompatible with the study requirements.
- Presence of skin diseases that could interfere with instrumental measurements.
- Pregnant or breastfeeding women, or women of childbearing potential unwilling to use precautions to avoid pregnancy.
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: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: The Active Product
Atopic cream with Picea abies extract
|
Base cosmetic formulation identical to the test product but without the active Picea abies resin extract.
Applied twice daily on clean and dry skin of the face and body for 21 days.
Outros nomes:
Commercially available emollient cream (Aqualan-L) used as an active comparator.
Applied twice daily on clean and dry skin of the face and body for 21 days.
Outros nomes:
|
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Comparador de Placebo: The Placebo
Atopic cream without Picea abies extract
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Commercially available emollient cream (Aqualan-L) used as an active comparator.
Applied twice daily on clean and dry skin of the face and body for 21 days.
Outros nomes:
Cosmetic cream containing Picea abies extract.
Applied twice daily on clean and dry skin of the face and body for 21 days.
Outros nomes:
|
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Comparador Ativo: Aqualan-L
Subjects apply the benchmark cream (Aqualan-L) twice daily on clean and dry skin of the face and body for 21 days.
|
Base cosmetic formulation identical to the test product but without the active Picea abies resin extract.
Applied twice daily on clean and dry skin of the face and body for 21 days.
Outros nomes:
Cosmetic cream containing Picea abies extract.
Applied twice daily on clean and dry skin of the face and body for 21 days.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in Transepidermal Water Loss (TEWL) on Cheekbones at Day 21
Prazo: Baseline (T0) and Day 21 (T21±2)
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Transepidermal water loss (TEWL) on the cheekbones will be measured using a Tewameter.
The outcome will be reported as the change from baseline to Day 21.
Values are expressed in g/m²/h.
|
Baseline (T0) and Day 21 (T21±2)
|
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Change From Baseline in Transepidermal Water Loss (TEWL) on Forearms at Day 21
Prazo: Baseline (T0) and Day 21 (T21±2)
|
Transepidermal water loss (TEWL) on the forearms will be measured using a Tewameter.
The outcome will be reported as the change from baseline to Day 21.
Values are expressed in g/m²/h.
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Baseline (T0) and Day 21 (T21±2)
|
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Change From Baseline in Skin Moisturization on Cheekbones at Day 21
Prazo: Baseline (T0) and Day 21 (T21±2)
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Skin moisturization on the cheekbones will be evaluated using a Corneometer.
The outcome will be reported as the change from baseline to Day 21.
Values are expressed in corneometric units (c.u.).
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Baseline (T0) and Day 21 (T21±2)
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Change From Baseline in Skin Moisturization on Forearms at Day 21
Prazo: Baseline (T0) and Day 21 (T21±2)
|
Skin moisturization on the forearms will be evaluated using a Corneometer.
The outcome will be reported as the change from baseline to Day 21.
Values are expressed in corneometric units (c.u.).
|
Baseline (T0) and Day 21 (T21±2)
|
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Change From Baseline in Skin Dryness Score at Day 21
Prazo: Baseline (T0) and Day 21 (T21±2)
|
Skin dryness will be assessed using the study-defined 5-point clinical score: 0 = none, 1 = very mild, 2 = mild, 3 = moderate, and 4 = severe.
Higher scores indicate greater severity.
The outcome will be reported as the change from baseline to Day 21.
|
Baseline (T0) and Day 21 (T21±2)
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Change From Baseline in Skin Desquamation Score at Day 21
Prazo: Baseline (T0) and Day 21 (T21±2)
|
Skin desquamation will be assessed using the study-defined 5-point clinical score: 0 = none, 1 = very mild, 2 = mild, 3 = moderate, and 4 = severe.
Higher scores indicate greater severity.
The outcome will be reported as the change from baseline to Day 21.
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Baseline (T0) and Day 21 (T21±2)
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Change from Baseline in Itching Sensation Score at Day 21
Prazo: Baseline (T0) and Day 21 (T21±2)
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Itching sensation will be assessed using the study-defined clinical score: 0 = absent itching, 1 = very mild itching, 2 = mild itching, 3 = moderate itching, 4 = severe itching.
The outcome will be reported as change from baseline to Day 21.
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Baseline (T0) and Day 21 (T21±2)
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Change from Baseline in Skin Redness Score at Day 21
Prazo: Baseline (T0) and Day 21 (T21±2)
|
Skin redness will be assessed using the study-defined clinical score: 0 = absent redness, 1 = very mild redness, 2 = mild redness, 3 = moderate redness, 4 = severe redness.
The outcome will be reported as change from baseline to Day 21.
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Baseline (T0) and Day 21 (T21±2)
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Change From Baseline in Stinging Sensation Score at Day 21
Prazo: Baseline (T0) and Day 21 (T21±2)
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Stinging sensation will be assessed using the study-defined 5-point clinical score: 0 = none, 1 = very mild, 2 = mild, 3 = moderate, and 4 = severe.
Higher scores indicate greater severity.
The outcome will be reported as the change from baseline to Day 21.
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Baseline (T0) and Day 21 (T21±2)
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Change From Baseline in Burning Sensation Score at Day 21
Prazo: Baseline (T0) and Day 21 (T21±2)
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Burning sensation will be assessed using the study-defined 5-point clinical score: 0 = none, 1 = very mild, 2 = mild, 3 = moderate, and 4 = severe.
Higher scores indicate greater severity.
The outcome will be reported as the change from baseline to Day 21.
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Baseline (T0) and Day 21 (T21±2)
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Change From Baseline in Skin Tightness Score at Day 21
Prazo: Baseline (T0) and Day 21 (T21±2)
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Skin tightness will be assessed using the study-defined 5-point clinical score: 0 = none, 1 = very mild, 2 = mild, 3 = moderate, and 4 = severe.
Higher scores indicate greater severity.
The outcome will be reported as the change from baseline to Day 21.
|
Baseline (T0) and Day 21 (T21±2)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Maryam Ghanbarirad, Ph.D., Repolar Pharmaceuticals Oy
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)
5 de janeiro de 2026
Conclusão Primária (Real)
18 de março de 2026
Conclusão do estudo (Real)
18 de março de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
24 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de maio de 2026
Primeira postagem (Real)
7 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
7 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de maio de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- IT0000844/25 rev02
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant data (IPD) are considered proprietary to the Sponsor.
To protect intellectual property and maintain commercial confidentiality, there are currently no plans to share de-identified IPD with external researchers.
Aggregated results and summary data will be made available through the clinical trial registry and potentially via peer-reviewed publication.
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 .