Evaluating the Effect of Bathing Additives in Atopic Dermatitis
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ClinicalTrials.gov Identifier: NCT04001855 |
Recruitment Status :
Terminated
(Investigator left university)
First Posted : June 28, 2019
Last Update Posted : June 4, 2021
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Condition or disease | Intervention/treatment | Phase |
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Atopic Dermatitis Eczema | Other: Dilute vinegar (acetic acid) Other: Dilute bleach | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized control split body study |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluating the Effect of Bathing Additives in Atopic Dermatitis |
Actual Study Start Date : | July 1, 2019 |
Actual Primary Completion Date : | May 31, 2020 |
Actual Study Completion Date : | May 31, 2020 |
Arm | Intervention/treatment |
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Experimental: Dilute vinegar vs. dilute bleach bath
Subjects will complete a total of 5 study visits over 11 days. At visits 1-4, subjects will soak their forearms in either dilute bleach or dilute vinegar for 10 minutes. At all visits, measurements of skin barrier function will be obtained using non-invasive, commercially-available devices. Non-invasive, non-painful tape stripping samples and skin culture swabs will also be collected.
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Other: Dilute vinegar (acetic acid)
Dilute vinegar baths or gauze soaks Other: Dilute bleach Dilute bleach baths or gauze soaks |
Experimental: Dilute vinegar vs. dilute bleach gauze soaks
Subjects will complete a total of two study visits over 21 days, and will be instructed to apply gauze soaks daily at home over the 21-day study period. At baseline and 21-day follow-up visits, measurements of skin barrier function will be obtained using non-invasive, commercially-available devices. Non-invasive, non-painful tape stripping samples and skin culture swabs will also be collected. Subjects will also be provided with a non-invasive skin barrier measurement device to take daily recordings at home.
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Other: Dilute vinegar (acetic acid)
Dilute vinegar baths or gauze soaks Other: Dilute bleach Dilute bleach baths or gauze soaks |
- Skin barrier function - Transepidermal water loss (TEWL) [ Time Frame: Up to 21 days ]Assess skin barrier function through measurement of transepidermal water loss (in g/m^2h) using a commercially-available, non-invasive device (Delfin VapoMeter: http://www.delfintech.com/en/product_information/vapometer/).
- Skin barrier function - Stratum corneum hydration [ Time Frame: Up to 21 days ]Assess skin barrier function through measurement of stratum corneum hydration (in arbitrary units) using a commercially-available, non-invasive device (Delfin MoistureMeterSC: http://www.delfintech.com/en/product_information/moisturemetersc/).
- Skin barrier function - pH [ Time Frame: Up to 21 days ]Assess skin barrier function through measurement of stratum corneum pH (in pH units) using a commercially-available, non-invasive device.
- Skin culture swab [ Time Frame: Up to 21 days ]Assess microbial composition via collection of non-invasive, non-painful skin culture swab samples.
- Change in Eczema Area and Severity Index (EASI) [ Time Frame: Up to 21 days. ]Clinical grading of atopic dermatitis/eczema severity (higher EASI scores indicating more severe AD).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 5 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and females, at least 5 years of age
- Subjects, parents/legal guardians must be able to comprehend and read the English language
- Subjects must have a diagnosis of atopic dermatitis (AD) by a board-certified dermatologist
Exclusion Criteria:
- Subjects who do not fit the inclusion criteria
- Subjects unable or unwilling to comply with the study procedures
- Concurrently have other inflammatory skin conditions
- Prior known allergies to any components of the materials used
- 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
- Those that are pregnant, prisoners or cognitively impaired
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001855
United States, Arizona | |
Banner University Medicine Dermatology | |
Tucson, Arizona, United States, 85718 |
Responsible Party: | University of Arizona |
ClinicalTrials.gov Identifier: | NCT04001855 |
Other Study ID Numbers: |
1906687954 |
First Posted: | June 28, 2019 Key Record Dates |
Last Update Posted: | June 4, 2021 |
Last Verified: | June 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Atopic Dermatitis Eczema |
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Acetic Acid Retinol acetate Anti-Bacterial Agents Anti-Infective Agents Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Anticarcinogenic Agents Protective Agents Antineoplastic Agents |