Clinical trial NCT02594969: The Effect of Diluted Sodium Hypochlorite Solution and Moisturizers on Skin Barrier Function in Atopic Dermatitis
Official title: The Effect of Diluted Sodium Hypochlorite Solution and Moisturizers on Skin Barrier Function in Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The goal is this study is to investigate the effects of dilute bleach on the skin of subjects with atopic dermatitis and those with healthy skin. The second goal is to evaluate the effects of different moisturizers on the skin barrier of subjects with and without atopic dermatitis. The investigators hypothesize that the bleach bath will increase the skin pH, decrease the skin hydration, and increase skin water loss in all study subjects. Secondly, the investigators hypothesize that moisturizers with the lowest pH and the highest water to oil ratio will result in improved skin barrier function. Furthermore, the investigators believe there will be a greater improvement in patients with atopic dermatitis.

Detailed description: The study has two main parts. Subjects in both groups will have one forearm in a dilute bleach bath and the other arm in a water bath for 10 minutes. The change in skin will be measured using different painless devices. The second part of the study involves application of 4 various moisturizers. The change in skin will be measured over a period of time using the non-invasive devices.

Eligibility criteria: Inclusion Criteria:

* Age 8 years to 65 years
* Has been diagnosed with atopic dermatitis by a board-certified dermatologist at UC Davis
* Subject/parents/legal guardians able to read and comprehend the study procedure and consent forms.

Exclusion Criteria:

* Those who are pregnant, prisoners, or cognitively impaired
* Those who do not fit the inclusion criteria

Primary outcomes:
measure: Change in transepidermal water loss post-bath immersion
timeFrame: 10 minutes post-bath immersion
Secondary outcomes:
measure: Change in transepidermal water loss after moisturizer application
timeFrame: up to 60 minutes post-moisturizer application
measure: Change in skin hydration after moisturizer application
timeFrame: up to 60 minutes post-moisturizer application
measure: Change in skin pH after moisturizer application
timeFrame: up to 60 minutes post-moisturizer application
measure: Change in skin hydration post-bath immersion
timeFrame: 10 minutes post-bath immersion
measure: Change in skin pH post-bath immersion
timeFrame: 10 minutes post-bath immersion
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Department of Dermatology
state: California
Study officials:
affiliation: UC Davis
name: Raja K Sivamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eichenfield LF. Consensus guidelines in diagnosis and treatment of atopic dermatitis. Allergy. 2004 Aug;59 Suppl 78:86-92. doi: 10.1111/j.1398-9995.2004.00569.x.
citation: Hanifin JM, Cooper KD, Ho VC, Kang S, Krafchik BR, Margolis DJ, Schachner LA, Sidbury R, Whitmore SE, Sieck CK, Van Voorhees AS. Guidelines of care for atopic dermatitis, developed in accordance with the American Academy of Dermatology (AAD)/American Academy of Dermatology Association "Administrative Regulations for Evidence-Based Clinical Practice Guidelines". J Am Acad Dermatol. 2004 Mar;50(3):391-404. doi: 10.1016/j.jaad.2003.08.003. No abstract available.
citation: Rippke F, Schreiner V, Doering T, Maibach HI. Stratum corneum pH in atopic dermatitis: impact on skin barrier function and colonization with Staphylococcus Aureus. Am J Clin Dermatol. 2004;5(4):217-23. doi: 10.2165/00128071-200405040-00002.
citation: Ryan C, Shaw RE, Cockerell CJ, Hand S, Ghali FE. Novel sodium hypochlorite cleanser shows clinical response and excellent acceptability in the treatment of atopic dermatitis. Pediatr Dermatol. 2013 May-Jun;30(3):308-15. doi: 10.1111/pde.12150.