NCT05918237

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

June 14, 2023

Last Update Submit

June 23, 2023

Conditions

Atopic Dermatitis Eczema

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    28 Days

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

    28 Days

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 Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ClinOhio Research Services, LLC

Columbus, Ohio, 43213, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label, single arm
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

June 26, 2023

Study Start

February 6, 2023

Primary Completion

April 28, 2023

Study Completion

April 28, 2023

Last Updated

June 26, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)