Back to resultsPilot Study to Test the Effects of Arctiva on Mild to Moderate Eczema
Primary Purpose
Atopic Dermatitis Eczema
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arctiva
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis Eczema
Eligibility Criteria
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
Sites / Locations
- ClinOhio Research Services, LLC
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT05918237
First Posted
June 14, 2023
Last Updated
June 23, 2023
Sponsor
ClinOhio Research Services, LLC
Collaborators
Arctiva Wellness LLC
1. Study Identification
Unique Protocol Identification Number
NCT05918237
Brief Title
Pilot Study to Test the Effects of Arctiva on Mild to Moderate Eczema
Official Title
Pilot Study to Test the Effects of Arctiva on Mild to Moderate Eczema
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
April 28, 2023 (Actual)
Study Completion Date
April 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ClinOhio Research Services, LLC
Collaborators
Arctiva Wellness LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis Eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open label, single arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Arctiva
Intervention Description
A colloidal oatmeal cream designed to stimulate healing and repair of damaged tissue naturally, working with the body instead of against it.
Primary Outcome Measure Information:
Title
Severity Scoring of Atopic Dermatitis Index (SCORAD) improvement [Timeframe : Baseline to Day 28]
Description
Change from Baseline to Day 28 in overall Severity Scoring of Atopic Dermatitis Index (SCORAD)
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Change from Baseline in Dermatology Life Quality Index (DLQI) [Timeframe: Baseline to Day 28]
Description
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.
Time Frame
28 Days
Title
Change from baseline in Patient-Oriented Eczema Measure (POEM). [ Time Frame: Baseline and 28 Days]
Description
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
Time Frame
28 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
ClinOhio Research Services, LLC
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study to Test the Effects of Arctiva on Mild to Moderate Eczema
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