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

Not Applicable

Completed

• Conditions: Atopic Dermatitis Eczema

• Registration Number: NCT05918237
• Lead Sponsor: ClinOhio Research Services, LLC

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.

Study Timeline

• Study Start: 2023-02-06
• Primary Completion: 2023-04-28
• Study Completion: 2023-04-28
• Status Verified: 2023-06
• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-23
• Last Update Submitted: 2023-06-23
• Study First Posted: 2023-06-26
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

ClinOhio Research Services, LLC; 🇺🇸 Columbus, Ohio, United States