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OpenTrials
Completed

NCT Number: NCT05918237

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

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

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Key information

Conditions

Atopic Dermatitis Eczema

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ClinOhio Research Services, LLC

Columbus, Ohio, 43213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arctiva

Other

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

Primary outcomes

  1. Severity Scoring of Atopic Dermatitis Index (SCORAD) improvement [Timeframe : Baseline to Day 28]

    Time frame: 28 Days

    Change from Baseline to Day 28 in overall Severity Scoring of Atopic Dermatitis Index (SCORAD)

Secondary outcomes

  1. Change from Baseline in Dermatology Life Quality Index (DLQI) [Timeframe: Baseline to Day 28]

    Time frame: 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.

  2. Change from baseline in Patient-Oriented Eczema Measure (POEM). [ Time Frame: Baseline and 28 Days]

    Time frame: 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

Sponsors and collaborators

Lead sponsor

ClinOhio Research Services, LLC

Industry

Collaborators

  • Arctiva Wellness LLC

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 26, 2023
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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