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Study was ceased due to Covid-19 epidemia.
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| Name | Class |
|---|---|
| Cliniscan Ltd | UNKNOWN |
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Atopic eczema is a chronic inflammatory skin disease associated with itch and inflammatory lesions in typical skin areas. The objective of this study is to investigate the effects of a cream containing berry and plant oils and humectants on atopic eczema and dry skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berry Oil Cream | Experimental | Study part 1: Administered to a chosen eczema lesion on randomized body half 1-2 times/d or more frequently (use reported to study logbook) for two weeks. Also administered to forearm (randomized body half) twice/d for two weeks. Study part 2: Administered to randomized body half 1-2 times/d for five weeks. |
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| Control | No Intervention | Study part 1: A chosen eczema lesion on randomized body half is an untreated control for two weeks. Also one forearm (on randomized body half) is a control with no treatment for two weeks. | |
| Reference cream | Active Comparator | A commercial reference cream, not containing berry and plant oils. Study part 2: Administered to randomized body half 1-2 times/d for five weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berry Oil Cream | Device | Cream containing berry and plant oils and humectants; a medical device product in development |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in severity of atopic eczema | Objective local Scoring Atopic Dermatitis (SCORAD) index. Scale range for objective local scorad in study part 1 (chosen eczema lesion) 0-63, in study part 2 (body half) 0-73. Decrease indicates better outcome/ milder symptoms. | Part 1: Baseline, 2 weeks. Part 2: Baseline, 5 weeks |
| Change in severity of symptoms | Modified Patient Oriented Eczema Measure (POEM) questionnaire. Scale range: 0-24. Decrease indicates better outcome/ milder symptoms. | Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks |
| Change in sensation of itch | Visual Analog Scale (VAS) evaluation. Scale range 0-10. Decrease indicates better outcome/ milder symptoms. | Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks |
| Change in transepidermal water loss (TEWL) | Measurement of TEWL (g/m2h) | Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks |
| Change in skin hydration | Measurement of moisture (capacitance, proportional to water content of skin) | Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks |
| Change in skin pH | Measurement of skin pH | Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptoms of itching, dryness, flaking of skin | Symptom logbooks: daily scoring from 0 (no symptoms) to 3 (severe symptoms) | Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Risto Oksman, MD | Cliniscan Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mehiläinen (Private Clinic) | Turku | Finland |
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Study has two parts. In part 1 the participants, care provider and outcome assessor know which treatment is given to each skin area. In part 2 participant, care provider, investigator and outcome assessor do not know which treatment is given to each skin area. Masking is done by identical cream tubes.
| Reference Cream | Other | Commercial refence cream not containing berry and plant oils. |
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