Finding Patterns In Clinical Trial Experiences of Patients With Eczema

• Sponsor: Power Life Sciences Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05747378
• Collaborator: (none)
• Enrollment: 500
• Anticipated Duration (Months): 24

Study Details

Study Description

Brief Summary

Historically, participation in clinical trials has been skewed towards certain groups. However, research on the factors that influence participation, both positive and negative, is limited.

Eczema clinical trial patients help us identify these factors by sharing trial experiences during the course of the observational medical study.

This study will include a diverse group of participants to gather a wide range of information on clinical trial experiences. The collected data will then be used to benefit future eczema patients who are considering participating in a clinical study.

Condition or Disease	Intervention/Treatment	Phase
Eczema

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Case-Crossover
• Time Perspective: Prospective
• Official Title: An In-depth Study Assessing Eczema Patients Experiences in Medical Trials
• Anticipated Study Start Date: Mar 17, 2023
• Anticipated Primary Completion Date: Mar 17, 2024
• Anticipated Study Completion Date: Mar 17, 2025

Outcome Measures

Primary Outcome Measures

1. Number of patients who decide to enroll in a clinical trial for eczema. [3 months]

2. Rate of patients who remain in an eczema clinical trial to completion. [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient has been diagnosed with eczema

• Patient is 18 years old

• Patient has self-identified as planning to enroll in an observational clinical study

Exclusion Criteria:

• Patient does not understand, sign, and return consent form

• Patient is pregnant

• Inability to perform regular electronic reporting

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Power Life Sciences Inc.

Investigators

• Study Director: Michael B Gill, Power Life Sciences Inc.

Study Documents (Full-Text)

• Informed Consent Form - Feb 17, 2023

More Information

Publications

• Allen SJ, Jordan S, Storey M, Thornton CA, Gravenor MB, Garaiova I, Plummer SF, Wang D, Morgan G. Probiotics in the prevention of eczema: a randomised controlled trial. Arch Dis Child. 2014 Nov;99(11):1014-9. doi: 10.1136/archdischild-2013-305799. Epub 2014 Jun 19.
• Sawangjit R, Dilokthornsakul P, Lloyd-Lavery A, Lai NM, Dellavalle R, Chaiyakunapruk N. Systemic treatments for eczema: a network meta-analysis. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD013206. doi: 10.1002/14651858.CD013206.pub2.
• Spada F, Harrison IP, Barnes TM, Greive KA, Daniels D, Townley JP, Mostafa N, Fong AT, Tong PL, Shumack S. Recruitment of adults with moderate eczema for a randomised trial: Comparison of traditional versus modern methods. Australas J Dermatol. 2021 Nov;62(4):e510-e515. doi: 10.1111/ajd.13699. Epub 2021 Sep 3.

• Responsible Party: Power Life Sciences Inc.
• ClinicalTrials.gov Identifier: NCT05747378
• Other Study ID Numbers: 82431237
• First Posted: Feb 28, 2023
• Last Update Posted: Feb 28, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Power Life Sciences Inc.: Eczema
• Additional relevant MeSH terms: Eczema

Study Results

No Results Posted as of Feb 28, 2023