CompletedNot Applicable

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

Italy66 participantsStarted 2026-01-05

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline (T0) and Day 21 (T21±2)

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

Timeframe: Baseline (T0) and Day 21 (T21±2)

Change From Baseline in Skin Moisturization on Cheekbones at Day 21

Timeframe: Baseline (T0) and Day 21 (T21±2)

Change From Baseline in Skin Moisturization on Forearms at Day 21

Timeframe: Baseline (T0) and Day 21 (T21±2)

Change From Baseline in Skin Dryness Score at Day 21

Timeframe: Baseline (T0) and Day 21 (T21±2)

Change From Baseline in Skin Desquamation Score at Day 21

Timeframe: Baseline (T0) and Day 21 (T21±2)

Change from Baseline in Itching Sensation Score at Day 21

Timeframe: Baseline (T0) and Day 21 (T21±2)

Trial details

NCT IDNCT07573592

SponsorRepolar Pharmaceuticals Oy

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-18

View on ClinicalTrials.gov More Atopy trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Baseline (T0) and Day 21 (T21±2)

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

Timeframe: Baseline (T0) and Day 21 (T21±2)

Change From Baseline in Skin Moisturization on Cheekbones at Day 21

Timeframe: Baseline (T0) and Day 21 (T21±2)

Change From Baseline in Skin Moisturization on Forearms at Day 21

Timeframe: Baseline (T0) and Day 21 (T21±2)

Change From Baseline in Skin Dryness Score at Day 21

Timeframe: Baseline (T0) and Day 21 (T21±2)

Change From Baseline in Skin Desquamation Score at Day 21

Timeframe: Baseline (T0) and Day 21 (T21±2)

Change from Baseline in Itching Sensation Score at Day 21

Timeframe: Baseline (T0) and Day 21 (T21±2)