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

Atopic Dermatitis Eczema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05918237
• Other study ID #: ECZPROTOCOLOHIO115
• Status: Completed
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: April 28, 2023

Study information

• Verified date: June 2023
• Source: ClinOhio Research Services, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 28, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis Eczema
• Dermatitis
• Eczema

Intervention

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

Locations

Country	Name	City	State
United States	ClinOhio Research Services, LLC	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
ClinOhio Research Services, LLC	Arctiva Wellness LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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