Atopic Dermatitis Eczema
Conditions
Brief summary
Up to 30 participants with mild to moderate atopic dermatitis/eczema will be enrolled to apply study Investigational Product for 4 weeks.
Detailed description
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.
Interventions
OTHERArctiva
A colloidal oatmeal cream designed to stimulate healing and repair of damaged tissue naturally, working with the body instead of against it.
Sponsors
Arctiva Wellness LLC
ClinOhio Research Services, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label, single arm
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity Scoring of Atopic Dermatitis Index (SCORAD) improvement [Timeframe : Baseline to Day 28] | 28 Days | Change from Baseline to Day 28 in overall Severity Scoring of Atopic Dermatitis Index (SCORAD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Dermatology Life Quality Index (DLQI) [Timeframe: Baseline to Day 28] | 28 Days | 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. |
| Change from baseline in Patient-Oriented Eczema Measure (POEM). [ Time Frame: Baseline and 28 Days] | 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 |
Countries
United States
Outcome results
None listed