CClinicalTrials.gg
TerminatedNCT03188653Updated Jun 4, 2021

Evaluating the Effects of Cleansers on the Skin

An interventional study of CeraVe® Eczema Soothing Body Wash and Cetaphil® RestoraDerm® Eczema Calming Body Wash in Atopic Dermatitis, sponsored by University of Arizona. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-04.

Sponsored by University of Arizona · Not applicable, Interventional, and Treatment

Why this study was terminated
Investigator left university
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Up to 50 subjects (up to 25 with healthy skin or 25 with atopic dermatitis) meeting the inclusion criteria will be enrolled in this study. A physical exam will be performed to ensure the subjects have healthy skin versus atopic dermatitis. For atopic dermatitis subjects, AD severity will be graded by the EASI score. Site randomization will be performed to determine which cleansers will be used for each of the 8 test sites (one site will be randomized to act as a control and not receive any cleanser). Baseline skin barrier function (TEWL, pH and hydration) will be measured. Then 1ml of each cleansers will be applied to the corresponding test sites, 2ml of tap water will be added, and lathered in a circular motion for 15 seconds. The sites will then be rinsed off with tap water for 15 seconds. Arms will be padded dry. Barrier functions will be measured again immediately after padding dry, and at 30, 60 and 90 minutes after.

02

Conditions studied

  • Atopic Dermatitis

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03

In context

Dermatitis

1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.

This study's enrollment of 20 is below the median of 64 across 1,131 interventional studies indexed under Dermatitis.

Browse Dermatitis studies →

Lead sponsor

University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Subjects who do not fit the inclusion criteria. Subjects unable to or unwilling to comply with the study procedures Concurrently have other inflammatory skin conditions. Prior known allergy to any components to of the cleansers tested A subject who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures.

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    CeraVe® Eczema Soothing Body Wash

    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

  • Active comparator
    Cetaphil® RestoraDerm® Eczema Calming Body Wash

    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

  • Active comparator
    Dove® Sensitive Skin Body Wash

    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

  • Active comparator
    Eucerin® Skin Calming Body Wash

    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

  • Active comparator
    Aveeno® Skin Relief Body Wash

    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

  • Active comparator
    MooGoo® Milk Wash

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

    Other: MooGoo® Milk Wash

  • Active comparator
    Free & Clear Liquid Cleanser

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

    Other: Free & Clear Liquid Cleanser

Interventions

  • OtherCeraVe® Eczema Soothing Body Wash

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

  • OtherCetaphil® RestoraDerm® Eczema Calming Body Wash

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

  • OtherDove® Sensitive Skin Body Wash

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

  • OtherEucerin® Skin Calming Body Wash

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

  • OtherAveeno® Skin Relief Body Wash

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

  • OtherMooGoo® Milk Wash

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

  • OtherFree & Clear Liquid Cleanser

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

06

What researchers measure

Primary outcomes

  1. Skin barrier function

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

    Time frame: 2 hours

Secondary outcomes

  1. Skin barrier function

    Stratum corneum hydration status will be measured using hand-held, noninvasive skin barrier measuring device (MoistureMeterSC).

    Time frame: 2 hours

  2. Skin pH

    Skin pH will be measured.

    Time frame: 2 hours

07

Study locations

1 site
  • University of Arizona - Banner University Medicine Dermatology
    Tucson, Arizona 85718, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03188653
Lead sponsor
University of Arizona
Responsible party
Sponsor
First posted
Jun 15, 2017
Start date
May 31, 2017
Primary completion
May 31, 2020
Completion
May 31, 2020
Last update
Jun 4, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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