Clinical Evaluation of an Atopic Skin Product Containing Picea Abies Resin Extract
4. května 2026 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
66
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Pavia
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San Martino Siccomario, Pavia, Itálie, 27028
- Complife Italia S.r.l
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: The Active Product
Atopic cream with Picea abies extract
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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.
Ostatní jména:
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.
Ostatní jména:
|
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Komparátor placeba: The Placebo
Atopic cream without Picea abies extract
|
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.
Ostatní jména:
Cosmetic cream containing Picea abies extract.
Applied twice daily on clean and dry skin of the face and body for 21 days.
Ostatní jména:
|
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Aktivní komparátor: 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.
Ostatní jména:
Cosmetic cream containing Picea abies extract.
Applied twice daily on clean and dry skin of the face and body for 21 days.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in Transepidermal Water Loss (TEWL) on Cheekbones at Day 21
Časové okno: 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.
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Baseline (T0) and Day 21 (T21±2)
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Change From Baseline in Transepidermal Water Loss (TEWL) on Forearms at Day 21
Časové okno: 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.
|
Baseline (T0) and Day 21 (T21±2)
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Change From Baseline in Skin Moisturization on Cheekbones at Day 21
Časové okno: 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
Časové okno: 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
Časové okno: 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.
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Baseline (T0) and Day 21 (T21±2)
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Change From Baseline in Skin Desquamation Score at Day 21
Časové okno: Baseline (T0) and Day 21 (T21±2)
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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
Časové okno: 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
Časové okno: Baseline (T0) and Day 21 (T21±2)
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: Maryam Ghanbarirad, Ph.D., Repolar Pharmaceuticals Oy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
5. ledna 2026
Primární dokončení (Aktuální)
18. března 2026
Dokončení studie (Aktuální)
18. března 2026
Termíny zápisu do studia
První předloženo
24. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
4. května 2026
První zveřejněno (Aktuální)
7. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
7. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
4. května 2026
Naposledy ověřeno
1. dubna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- IT0000844/25 rev02
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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