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Clinical Evaluation of an Atopic Skin Product Containing Picea Abies Resin Extract

4 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

66

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Italia
    • Pavia
      • San Martino Siccomario, Pavia, Italia, 27028
        • Complife Italia S.r.l

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: The Active Product
Atopic cream with Picea abies extract
Altro: Placebo
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.
Altri nomi:
  • Base formulation
Altro: Aqualan-L Cream
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.
Altri nomi:
  • Benchmark emollient
Comparatore placebo: The Placebo
Atopic cream without Picea abies extract
Altro: Aqualan-L Cream
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.
Altri nomi:
  • Benchmark emollient
Altro: Atopic cream with Picea abies resin extract
Cosmetic cream containing Picea abies extract. Applied twice daily on clean and dry skin of the face and body for 21 days.
Altri nomi:
  • Abilar Atopic
Comparatore attivo: Aqualan-L
Subjects apply the benchmark cream (Aqualan-L) twice daily on clean and dry skin of the face and body for 21 days.
Altro: Placebo
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.
Altri nomi:
  • Base formulation
Altro: Atopic cream with Picea abies resin extract
Cosmetic cream containing Picea abies extract. Applied twice daily on clean and dry skin of the face and body for 21 days.
Altri nomi:
  • Abilar Atopic

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Transepidermal Water Loss (TEWL) on Cheekbones at Day 21
Lasso di tempo: Baseline (T0) and Day 21 (T21±2)
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)
Change From Baseline in Transepidermal Water Loss (TEWL) on Forearms at Day 21
Lasso di tempo: 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)
Change From Baseline in Skin Moisturization on Cheekbones at Day 21
Lasso di tempo: Baseline (T0) and Day 21 (T21±2)
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.).
Baseline (T0) and Day 21 (T21±2)
Change From Baseline in Skin Moisturization on Forearms at Day 21
Lasso di tempo: 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)
Change From Baseline in Skin Dryness Score at Day 21
Lasso di tempo: 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)
Change From Baseline in Skin Desquamation Score at Day 21
Lasso di tempo: 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.
Baseline (T0) and Day 21 (T21±2)
Change from Baseline in Itching Sensation Score at Day 21
Lasso di tempo: Baseline (T0) and Day 21 (T21±2)
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.
Baseline (T0) and Day 21 (T21±2)
Change from Baseline in Skin Redness Score at Day 21
Lasso di tempo: 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.
Baseline (T0) and Day 21 (T21±2)
Change From Baseline in Stinging Sensation Score at Day 21
Lasso di tempo: Baseline (T0) and Day 21 (T21±2)
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.
Baseline (T0) and Day 21 (T21±2)
Change From Baseline in Burning Sensation Score at Day 21
Lasso di tempo: Baseline (T0) and Day 21 (T21±2)
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.
Baseline (T0) and Day 21 (T21±2)
Change From Baseline in Skin Tightness Score at Day 21
Lasso di tempo: Baseline (T0) and Day 21 (T21±2)
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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Repolar Pharmaceuticals Oy

Collaboratori

Business Finland
Complife Italia Srl

Investigatori

  • Direttore dello studio: Maryam Ghanbarirad, Ph.D., Repolar Pharmaceuticals Oy

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 gennaio 2026

Completamento primario (Effettivo)

18 marzo 2026

Completamento dello studio (Effettivo)

18 marzo 2026

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 maggio 2026

Primo Inserito (Effettivo)

7 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • IT0000844/25 rev02

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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