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

Sponsor

ClinOhio Research Services, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT05918237

Collaborator

Arctiva Wellness LLC (Industry)

Enrollment

Location

2.7

Actual Duration (Months)

11.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis Eczema	Other: Arctiva	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open label, single armOpen label, single arm

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 6, 2023

Actual Primary Completion Date :

Apr 28, 2023

Actual Study Completion Date :

Apr 28, 2023

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ClinOhio Research Services, LLC	Columbus	Ohio	United States	43213

Sponsors and Collaborators

ClinOhio Research Services, LLC
Arctiva Wellness LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ClinOhio Research Services, LLC

ClinicalTrials.gov Identifier:

NCT05918237

Other Study ID Numbers:

ECZPROTOCOLOHIO115

First Posted:

Jun 26, 2023

Last Update Posted:

Jun 26, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dermatitis

Eczema

Study Results

No Results Posted as of Jun 26, 2023