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

ClinOhio Research Services, LLC30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis Eczema

Interventions

ArctivaOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

ClinOhio Research Services, LLC

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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)

Time frame: 28 Days

Secondary Outcomes

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.

Time frame: 28 Days

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

Time frame: 28 Days

Data from ClinicalTrials.gov

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