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

NCT ID: NCT05918237

Last Updated: 2023-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-06

Study Completion Date

2023-04-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Atopic Dermatitis Eczema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label, single arm
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Arctiva

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arctiva Wellness LLC

INDUSTRY

Sponsor Role collaborator

ClinOhio Research Services, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ClinOhio Research Services, LLC

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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ECZPROTOCOLOHIO115

Identifier Type: -

Identifier Source: org_study_id

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