Protocol for Eczema

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Center for Clinical Studies, Houston, TX
Eczema
topical colloidal oatmeal formulation with a modified plant oil - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a single-center, randomized, blinded, controlled trial assessing the effects on the skin microbiome in patients with eczema of amending a standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with a modified plant oil ("Activated Oil", AO)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 8 Secondary · Reporting Duration: 14 days

14 days
Atopic Dermatitis Severity Index (ADSI) score
Change in Eczema Area and Severity Index (EASI) score
Change in Shannon Diversity Index between the target lesion site and non-lesion site
Change in absolute abundance of S. aureus and S. epidermidis on target lesion versus non-lesion site.
Change in absolute abundance of S. aureus on target lesion site
Change in relative abundance of S. aureus on non-lesion site
Difference in Eczema Area and Severity Index (EASI) score
Difference in Shannon Diversity Index between the target lesion site and non-lesion site
Difference in absolute abundance of S. aureus and S. epidermidis on target lesion versus non-lesion site.
Reduction in absolute abundance of S. aureus on target lesion site
Reduction in relative abundance of S. aureus on non-lesion site

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control
1 of 2
Protocol
1 of 2
Active Control
Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Protocol · No Placebo Group · N/A

Protocol
Other
Experimental Group · 1 Intervention: topical colloidal oatmeal formulation with a modified plant oil · Intervention Types: Other
Control
Other
ActiveComparator Group · 1 Intervention: topical colloidal oatmeal formulation · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 14 days
Closest Location: Center for Clinical Studies · Houston, TX
Photo of Houston  1Photo of Houston  2Photo of Houston  3
2007First Recorded Clinical Trial
19 TrialsResearching Eczema
89 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to comply with all study procedures and are available for the duration of the study.
You have mild to moderate eczema.
You are able to administer topical medication and be willing to adhere to the study interventions.
You agree to follow the lifestyle considerations set out in the study protocol.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.