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

4. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

66

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: The Active Product
Atopic cream with Picea abies extract
Annen: 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.
Andre navn:
  • Base formulation
Annen: 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.
Andre navn:
  • Benchmark emollient
Placebo komparator: The Placebo
Atopic cream without Picea abies extract
Annen: 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.
Andre navn:
  • Benchmark emollient
Annen: 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.
Andre navn:
  • Abilar Atopic
Aktiv komparator: Aqualan-L
Subjects apply the benchmark cream (Aqualan-L) twice daily on clean and dry skin of the face and body for 21 days.
Annen: 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.
Andre navn:
  • Base formulation
Annen: 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.
Andre navn:
  • Abilar Atopic

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Transepidermal Water Loss (TEWL) on Cheekbones at Day 21
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Repolar Pharmaceuticals Oy

Samarbeidspartnere

Business Finland
Complife Italia Srl

Etterforskere

  • Studieleder: Maryam Ghanbarirad, Ph.D., Repolar Pharmaceuticals Oy

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. januar 2026

Primær fullføring (Faktiske)

18. mars 2026

Studiet fullført (Faktiske)

18. mars 2026

Datoer for studieregistrering

Først innsendt

24. april 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

7. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • IT0000844/25 rev02

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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