AtopyNCT07573592
Clinical Evaluation of an Atopic Skin Product Containing Picea Abies Resin Extract
A study testing Atopic cream with Picea abies resin extract and Aqualan-L Cream in people with Atopy and Skin Barrier to Water Loss, run by Repolar Pharmaceuticals Oy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopy, Skin Barrier to Water Loss
- What is being tested?
- Atopic cream with Picea abies resin extract and Aqualan-L Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jan 2026to 18 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atopy, Skin Barrier to Water Loss
- Being tested
- Atopic cream with Picea abies resin extract, Placebo, Aqualan-L Cream
- Keywords
- Atopy-prone skin, Picea abies resin extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atopic cream with Picea abies resin extractOther
Also called Abilar Atopic
Cosmetic cream containing Picea abies extract. Applied twice daily on clean and dry skin of the face and body for 21 days.
PlaceboOther
Also called Base formulation
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.
Aqualan-L CreamOther
Also called Benchmark emollient
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.
| Study group | Role | What they receive |
|---|---|---|
| The Active Product | Experimental | Atopic cream with Picea abies extract Receives: Other: Placebo; Other: Aqualan-L Cream |
| The Placebo | Placebo comparator | Atopic cream without Picea abies extract Receives: 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. Receives: Other: Atopic cream with Picea abies resin extract; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.).
Measured: 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.).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T0) and Day 21 (T21±2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start5 Jan 2026
- Primary completion18 Mar 2026
- Study completion18 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repolar Pharmaceuticals Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Complife Italia Srl, Business Finland
- Responsible party
- Sponsor
- Investigators
- Maryam Ghanbarirad, Ph.D., Study director, Repolar Pharmaceuticals Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573592
- Sponsor's protocol ID
- IT0000844/25 rev02
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical-Instrumental Evaluation of the Efficacy of Two Cosmetic Products in Comparison: Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT07573592
- Acronym / sponsor ID
- IT0000844/25 rev02
- Conditions
- Atopy, Skin Barrier to Water Loss
- Keywords
- Atopy-prone skin, Picea abies resin extract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Repolar Pharmaceuticals OyIndustry (pharma, biotech, devices)
- Collaborators
- Complife Italia Srl, Business Finland
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 18 Mar 2026 (actual)
- Study completion
- 18 Mar 2026 (actual)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The Active Product | Experimental | Other: Placebo, Other: Aqualan-L CreamAtopic cream with Picea abies extract |
| The Placebo | Placebo comparator | Other: Atopic cream with Picea abies resin extract, Other: Aqualan-L CreamAtopic cream without Picea abies extract |
| Aqualan-L | Active comparator | Other: Atopic cream with Picea abies resin extract, Other: PlaceboSubjects apply the benchmark cream (Aqualan-L) twice daily on clean and dry skin of the face and body for 21 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atopic cream with Picea abies resin extractAlso: Abilar AtopicCosmetic cream containing Picea abies extract. Applied twice daily on clean and dry skin of the face and body for 21 days. | Other | Aqualan-L, The Placebo |
| PlaceboAlso: Base formulationBase 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 | Aqualan-L, The Active Product |
| Aqualan-L CreamAlso: Benchmark emollientCommercially 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 | The Active Product, The Placebo |
Primary outcome
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.
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.
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.).
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.).
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryam Ghanbarirad, Ph.D. study director
Repolar Pharmaceuticals Oy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atopic cream with Picea abies resin extract and Aqualan-L Cream in people with Atopy and Skin Barrier to Water Loss, run by Repolar Pharmaceuticals Oy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Transepidermal Water Loss (TEWL) on Cheekbones at Day 21 (time frame: Baseline (T0) and Day 21 (T21±2)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.