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Completed

NCT Number: NCT07573592

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

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.

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Key information

Conditions

Atopy Skin Barrier to Water Loss

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complife Italia S.r.l

San Martino Siccomario, Pavia, 27028, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Abilar Atopic

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.

Other names: Base formulation

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.

Other names: Benchmark emollient

Primary outcomes

  1. Change From Baseline in Transepidermal Water Loss (TEWL) on Cheekbones at Day 21

    Time frame: 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.

  2. Change From Baseline in Transepidermal Water Loss (TEWL) on Forearms at Day 21

    Time frame: 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.

  3. Change From Baseline in Skin Moisturization on Cheekbones at Day 21

    Time frame: 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.).

  4. Change From Baseline in Skin Moisturization on Forearms at Day 21

    Time frame: 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.).

  5. Change From Baseline in Skin Dryness Score at Day 21

    Time frame: 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.

  6. Change From Baseline in Skin Desquamation Score at Day 21

    Time frame: 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.

  7. Change from Baseline in Itching Sensation Score at Day 21

    Time frame: 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.

  8. Change from Baseline in Skin Redness Score at Day 21

    Time frame: 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.

  9. Change From Baseline in Stinging Sensation Score at Day 21

    Time frame: 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.

  10. Change From Baseline in Burning Sensation Score at Day 21

    Time frame: 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.

  11. Change From Baseline in Skin Tightness Score at Day 21

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Repolar Pharmaceuticals Oy

Industry

Collaborators

  • Business Finland
  • Complife Italia Srl

Registry information

Official study title

Clinical-Instrumental Evaluation of the Efficacy of Two Cosmetic Products in Comparison: Placebo Controlled Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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