Clinical Evaluation of an Atopic Skin Product Containing Picea Abies Resin Extract
4. maj 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
66
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pavia
-
San Martino Siccomario, Pavia, Italien, 27028
- Complife Italia S.r.l
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde 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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
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 navne:
|
|
Placebo komparator: 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.
Andre navne:
Cosmetic cream containing Picea abies extract.
Applied twice daily on clean and dry skin of the face and body for 21 days.
Andre navne:
|
|
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.
|
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 navne:
Cosmetic cream containing Picea abies extract.
Applied twice daily on clean and dry skin of the face and body for 21 days.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Maryam Ghanbarirad, Ph.D., Repolar Pharmaceuticals Oy
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. januar 2026
Primær færdiggørelse (Faktiske)
18. marts 2026
Studieafslutning (Faktiske)
18. marts 2026
Datoer for studieregistrering
Først indsendt
24. april 2026
Først indsendt, der opfyldte QC-kriterier
4. maj 2026
Først opslået (Faktiske)
7. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. maj 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- IT0000844/25 rev02
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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