Atopy, Skin Barrier to Water Loss
Conditions
Keywords
Atopy-prone skin, Picea abies resin extract
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.
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.
Interventions
OTHERAtopic 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.
OTHERPlacebo
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.
OTHERAqualan-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.
Sponsors
Repolar Pharmaceuticals Oy
Complife Italia Srl
Business Finland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Transepidermal Water Loss (TEWL) on Cheekbones at Day 21 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
Italy
Contacts
STUDY_DIRECTORMaryam Ghanbarirad, Ph.D.
Repolar Pharmaceuticals Oy
Outcome results
None listed