NCT03188653

Brief Summary

This will be a single visit study that will take approximately 2 hours. Up to 50 subjects (up to 25 healthy subjects, and up to 25 subjects with AD) from BUMC dermatology clinics will be enrolled in this study and randomized to receive the 7 cleansers on 7 test spots on their upper extremities. One spot will serve as a control and not receive any cleanser. Each spot will be cleansed with the corresponding cleanser for 15 seconds then rinsed off with tap water. Skin barrier will be measured at baseline, immediately after, 30, 60 and 90 minutes after rinse off.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

May 30, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

May 31, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

3 years

First QC Date

May 30, 2017

Last Update Submit

June 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Skin barrier function

    Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring device (VapoMeter).

    2 hours

Secondary Outcomes (2)

  • Skin barrier function

    2 hours

  • Skin pH

    2 hours

Study Arms (7)

CeraVe® Eczema Soothing Body Wash

ACTIVE COMPARATOR

One of the 7 forearm locations will be selected to receive CeraVe® Eczema Soothing Body Wash one time only.

Other: CeraVe® Eczema Soothing Body Wash

Cetaphil® RestoraDerm® Eczema Calming Body Wash

ACTIVE COMPARATOR

One of the 7 forearm locations will be selected to receive Cetaphil® RestoraDerm® Eczema Calming Body Wash one time only.

Other: Cetaphil® RestoraDerm® Eczema Calming Body Wash

Dove® Sensitive Skin Body Wash

ACTIVE COMPARATOR

One of the 7 forearm locations will be selected to receive Dove® Sensitive Skin Body Wash one time only.

Other: Dove® Sensitive Skin Body Wash

Eucerin® Skin Calming Body Wash

ACTIVE COMPARATOR

One of the 7 forearm locations will be selected to receive Eucerin® Skin Calming Body Wash one time only.

Other: Eucerin® Skin Calming Body Wash

Aveeno® Skin Relief Body Wash

ACTIVE COMPARATOR

One of the 7 forearm locations will be selected to receive Aveeno® Skin Relief Body Wash one time only.

Other: Aveeno® Skin Relief Body Wash

MooGoo® Milk Wash

ACTIVE COMPARATOR

One of the 7 forearm locations will be selected to receive MooGoo® Milk Wash one time only.

Other: MooGoo® Milk Wash

Free & Clear Liquid Cleanser

ACTIVE COMPARATOR

One of the 7 forearm locations will be selected to receive Free \& Clear Liquid Cleanser

Other: Free & Clear Liquid Cleanser

Interventions

One of the 7 arm locations will be selected to receive CeraVe® Eczema Soothing Body Wash

CeraVe® Eczema Soothing Body Wash

One of the 7 arm locations will be selected to receive Cetaphil® RestoraDerm® Eczema Calming Body Wash

Cetaphil® RestoraDerm® Eczema Calming Body Wash

One of the 7 arm locations will be selected to receive Dove® Sensitive Skin Body Wash

Dove® Sensitive Skin Body Wash

One of the 7 arm locations will be selected to receive Eucerin® Skin Calming Body Wash

Eucerin® Skin Calming Body Wash

One of the 7 arm locations will be selected to receive Aveeno® Skin Relief Body Wash

Aveeno® Skin Relief Body Wash

One of the 7 arm locations will be selected to receive MooGoo® Milk Wash

MooGoo® Milk Wash

One of the 7 arm locations will be selected to receive Free \& Clear Liquid Cleanser

Free & Clear Liquid Cleanser

Eligibility Criteria

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

You may qualify if:

  • Male and female, at least 18 years of age Subject must be able to comprehend and read the English language. Healthy skin without concurrent atopic dermatitis or diagnosed with atopic dermatitis by a dermatologist

You may not qualify if:

  • Subject unable to speak or read the English language, since all consents and instructions will be provided in English.
  • Those that are prisoners or cognitively impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona - Banner University Medicine Dermatology

Tucson, Arizona, 85718, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 15, 2017

Study Start

May 31, 2017

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

June 4, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations