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

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.

Study Overview

• Status: Completed
• Conditions: Atopy; Skin Barrier to Water Loss
• Intervention / Treatment: Other: Placebo; Other: Aqualan-L Cream; Other: Atopic cream with Picea abies resin extract

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Active Product; Atopic cream with Picea abies extract	Other: 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.; Other Names: Base formulation; Other: 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.; Other Names: Benchmark emollient
Placebo Comparator: The Placebo; Atopic cream without Picea abies extract	Other: 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.; Other Names: Benchmark emollient; Other: 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.; Other Names: Abilar Atopic
Active Comparator: Aqualan-L; Subjects apply the benchmark cream (Aqualan-L) twice daily on clean and dry skin of the face and body for 21 days.	Other: 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.; Other Names: Base formulation; Other: 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.; Other Names: Abilar Atopic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Transepidermal Water Loss (TEWL) on Cheekbones at Day 21	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	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	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	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	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	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	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	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	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	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	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)

Collaborators and Investigators

• Sponsor: Repolar Pharmaceuticals Oy
• Collaborators: Business Finland; Complife Italia Srl
• Investigators: Study Director: Maryam Ghanbarirad, Ph.D., Repolar Pharmaceuticals Oy

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2026
• Primary Completion (Actual): March 18, 2026
• Study Completion (Actual): March 18, 2026

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Atopy-prone skin; Picea abies resin extract
• Other Study ID Numbers: IT0000844/25 rev02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No