Efficacy and Safety of a Topical Botanical Extract Formulation for Skin Barrier Repair
A Single-Center, Double-Blinded, Randomized, Placebo-Controlled, Prospective Study to Evaluate the Efficacy and Safety of a Botanical Extract in Skincare Formulations for Skin Barrier Repair on Healthy Volunteers
This is a single-center, double-blinded, placebo-controlled, prospective clinical study designed to evaluate the skin barrier repair efficacy and local tolerance of topical cosmetic formulations containing a botanical extract. Skin barrier challenge is induced via standardized tape stripping on the volar forearm of healthy subjects. The study will evaluate and compare the repair kinetics of two concentrations of the active formulation, a vehicle, and an untreated control zone over a 14-day application period.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Healthy female subjects will undergo a standardized skin barrier challenge (tape-stripping) on designated zones of their volar forearms at baseline. Formulations containing different concentrations of a botanical extract (Active Formulation A and Active Formulation B), a vehicle control, and an untreated control will be assigned to the randomized zones. Products will be applied topically twice daily for 14 days. Skin barrier repair efficacy will be assessed using clinical gradings and instrumental measurements, including Trans-Epidermal Water Loss (TEWL) and skin hydration. Local tolerance will be evaluated via clinical grading. Non-invasive skin surface biomaterial collection may be performed at designated time points for skin proteomics and lipidomics analysis.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
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Shanghai, China
- L'OREAL
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Chinese women aged 35 to 60 years in good general health.
- Self-reported dry skin type.
- a hydration index < 35 and a trans-epidermal water loss (TEWL) ≥ 6g.m-2.h-1 on both anterior sides of the forearms at screening.
- Willingness to avoid excessive sun exposure and comply with all study procedures including tape stripping and biosampling.
- Bilateral forearms clear of scars, wounds, or significant pigment spots.
Exclusion Criteria:
- Current pregnancy, breastfeeding, or planning to become pregnant.
- Current smokers or history of smoking within the last 6 months (including e-cigarettes/nicotine products).
- History of facial cosmetic procedures (fillers, lasers, implants, Botox, etc.).
- Active systemic or localized skin diseases (acne, eczema, psoriasis, atopic dermatitis).
- Allergies to cosmetics, personal care products, or their ingredients.
- Excessive UV exposure or frequent sauna/water sports usage.
- Use of antihistamines, antibiotics, corticosteroids, or NSAIDs within the relevant washout periods.
- Participation in any other clinical trial within the past 30 days.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Active Formulation A
Zones applying 0.24% active formulation |
Topical skincare formulation containing Botanical Extract (Concentration A). Applied twice daily for 14 days. |
|
Experimental: Active Formulation B
Zones applying 0.05% active formulation |
Topical skincare formulation containing Botanical Extract (Concentration B). Applied twice daily for 14 days. |
|
Comparador de Placebo: Vehicle Control
Zones applying the formulation base without active extract |
Topical formulation base (identical to investigational products but without the active botanical extract). Applied twice daily for 14 days. |
|
Sem intervenção: Untreated Zone
Control Zone on the forearm with no product application: Tape stripped zone left untreated to monitor natural physiological repairing kinetics |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Clinical Scoring (Erythema, Dryness, Desquamation, Roughness, Edema, PIH)
Prazo: Baseline, Tafter (immediately after tape stripping), T3h (3 hours after 1st product application), Day 1, Day 3, Day 7, and Day 14
|
Dermatological grading of erythema, dryness, roughness, edema, desquamation and post-inflammatory hyperpigmentation using standard clinical scales |
Baseline, Tafter (immediately after tape stripping), T3h (3 hours after 1st product application), Day 1, Day 3, Day 7, and Day 14
|
|
Hydration
Prazo: Baseline, Tafter (right after tape stripping), Timm (immediately after 1st product application), T1h(1 hour after 1st product application), T3h(3 hours after 1st product application), Day 1, Day 3, Day 7, and Day 14
|
Hydration index measured using Corneometer |
Baseline, Tafter (right after tape stripping), Timm (immediately after 1st product application), T1h(1 hour after 1st product application), T3h(3 hours after 1st product application), Day 1, Day 3, Day 7, and Day 14
|
|
TEWL
Prazo: Baseline, post-stripping (Tafter), immediately post-first application (Timm), 1 hour post-first application (T1h), 3 hours post-first application (T3h), Day 1, Day 3, Day 7, and Day 14.
|
Trans-epidermal water loss using Vapometer |
Baseline, post-stripping (Tafter), immediately post-first application (Timm), 1 hour post-first application (T1h), 3 hours post-first application (T3h), Day 1, Day 3, Day 7, and Day 14.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Skin Structural Changes
Prazo: Baseline, Day 3, Day 7, and Day 14
|
Non-invasive evaluation of epidermis and dermis thickness/density using high-frequency ultrasound |
Baseline, Day 3, Day 7, and Day 14
|
|
Epidermal Proteomic and Lipidomic Profile
Prazo: Baseline, Day 7
|
Characterization of stratum corneum biomarkers obtained via non-invasive tape-stripping samplings. |
Baseline, Day 7
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- ACR_EV_25-11289
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