Pilot Study to Test the Effects of Arctiva on Mild to Moderate Eczema

Study Overview
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Brief Summary
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Up to 30 participants with mild to moderate atopic dermatitis/eczema will be enrolled to apply study Investigational Product for 4 weeks.

Detailed Description
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This will be a 4-week single arm study. This study will be executed by one clinical research company in one research center accruing 30 subjects with mild to moderate Eczema/atopic dermatitis. Patients ages 18-75, will be enrolled. Subjects that are enrolled will be placed on Locus's Over The Counter cream Arctiva twice per day for 4 weeks.

Official Title
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Pilot Study to Test the Effects of Arctiva on Mild to Moderate Eczema

Conditions
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Atopic Dermatitis Eczema

Intervention / Treatment
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* Other: Arctiva


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Female;18-75 years of age Have a clinical diagnosis of Mild to Moderate Eczema or Atopic Dermatitis Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to the start of any screening procedure Exclusion Criteria: Patients using topical corticosteroids steroidal creams and other agents within 7 days prior to first dose of trial Eczema treatment. Use of systemic corticosteroids or other agents for atopic dermatitis within 4 weeks prior to first dose of trial treatment. Active bacterial, viral, or fungal skin infections

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open label, single arm
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Arctiva|A colloidal oatmeal cream designed to stimulate healing and repair of damaged tissue naturally, working with the body instead of against it.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity Scoring of Atopic Dermatitis Index (SCORAD) improvement [Timeframe : Baseline to Day 28] | Change from Baseline to Day 28 in overall Severity Scoring of Atopic Dermatitis Index (SCORAD) | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Dermatology Life Quality Index (DLQI) [Timeframe: Baseline to Day 28] | Change from baseline to Day 28 in Dermatology Life Quality Index (DLQI) evaluating the impact on Quality of life scale: Very much ; A lot; a little or Not at all. | 28 Days | 
| Change from baseline in Patient-Oriented Eczema Measure (POEM). [ Time Frame: Baseline and 28 Days] | Change from baseline to Day 28 in Patient-Oriented Eczema Measure (POEM) investigating the number of days patients have been subjected, due to eczema, to itchy skin, sleep disturbance; skin bleeding; skin weeping; skin cracked; skin flaking and skin dryness. Scale defined as : 0 = no days; 1= 1-2 days; 2= 3-4 days; 3= 5-6 days; 4 = everyday | 28 Days |