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

NCT07573592 | Completed

• 1 other identifier: IT0000844/25 rev02
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopy; Skin Barrier to Water Loss

Keywords

Atopy-prone skin; Picea abies resin extract

Outcome Measures

Primary Outcomes (11)

• 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)

Study Arms (3)

The Active Product

EXPERIMENTAL

Atopic cream with Picea abies extract

Other: Placebo; Other: Aqualan-L Cream

The Placebo

PLACEBO COMPARATOR

Atopic cream without Picea abies extract

Other: Atopic cream with Picea abies resin extract; Other: Aqualan-L Cream

Aqualan-L

ACTIVE COMPARATOR

Subjects apply the benchmark cream (Aqualan-L) twice daily on clean and dry skin of the face and body for 21 days.

Other: Atopic cream with Picea abies resin extract; Other: Placebo

Interventions

Atopic cream with Picea abies resin extract OTHER

Cosmetic cream containing Picea abies extract. Applied twice daily on clean and dry skin of the face and body for 21 days.

Also known as: Abilar Atopic

Aqualan-L; The Placebo

Placebo OTHER

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.

Also known as: Base formulation

Aqualan-L; The Active Product

Aqualan-L Cream OTHER

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.

Also known as: Benchmark emollient

The Active Product; The Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Repolar Pharmaceuticals Oy: lead
• Complife Italia Srl: collaborator
• Business Finland: collaborator

Study Sites (1)

Complife Italia S.r.l

San Martino Siccomario, Pavia, 27028, Italy

Location

Study Officials

• Maryam Ghanbarirad, Ph.D.

  Repolar Pharmaceuticals Oy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 7, 2026
• Study Start: January 5, 2026
• Primary Completion: March 18, 2026
• Study Completion: March 18, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)