Twice Daily Versus Twice Weekly Soak-and-Seal Baths in Pediatric Atopic Dermatitis
NCT ID: NCT03397979
Last Updated: 2018-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
63 participants
INTERVENTIONAL
2011-11-14
2017-03-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Observational Evaluation of Atopic Dermatitis in Pediatric Patients
NCT03687359
Dilute Bleach Baths in Pediatric Patients With Atopic Dermatitis
NCT01286220
The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis
NCT00179959
Effect of S. Aureus Skin Decolonization on Disease Severity in Atopic Dermatitis Patients
NCT06397781
Pediatric Atopic Dermatitis (AD) Internet Survey
NCT01385527
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Frequent soaking baths
Frequent soaking baths, in this study, is defined as twice daily soaking baths for 15-20 minutes, over 2 weeks. However, this is a crossover study design with two interventions: 1) Infrequent soaking baths, as defined in the first arm description above, and 2) Frequent soaking baths, as defined above in this arm description. All subjects in the study will undergo both interventions, but in different order. Thus, this is a study comparing Infrequent Versus Frequent Soaking Baths. Each subject serves as their own control.
Infrequent versus Frequent Soaking Baths
Submersion of skin, affected by atopic dermatitis, in a bathtub filled with luke-warm water, where the frequency and duration of these baths are varied, to look for any differential effect.
Infrequent soaking baths
Infrequent soaking baths, in this study, is defined as twice a week soaking baths for 10 minutes or less, over 2 weeks. However, this is a crossover study design with two interventions: 1) Infrequent soaking baths, as defined above, and 2) Frequent soaking baths (defined as twice daily soaking baths for 15-20 minutes, over 2 weeks). All subjects in the study will undergo both interventions, but in different order. Thus, this is a study comparing Infrequent Versus Frequent Soaking Baths. Each subject serves as their own control.
Infrequent versus Frequent Soaking Baths
Submersion of skin, affected by atopic dermatitis, in a bathtub filled with luke-warm water, where the frequency and duration of these baths are varied, to look for any differential effect.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Infrequent versus Frequent Soaking Baths
Submersion of skin, affected by atopic dermatitis, in a bathtub filled with luke-warm water, where the frequency and duration of these baths are varied, to look for any differential effect.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
6 Months
11 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MaineHealth
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ivan Cardona
Clinical Assistant Professor, Tufts University School of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ivan D Cardona, M.D.
Role: PRINCIPAL_INVESTIGATOR
Allergy & Asthma Associates of Maine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Allergy and Asthma Associates of Maine
Portland, Maine, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. doi: 10.1056/NEJMra074081. No abstract available.
Elias PM, Hatano Y, Williams ML. Basis for the barrier abnormality in atopic dermatitis: outside-inside-outside pathogenic mechanisms. J Allergy Clin Immunol. 2008 Jun;121(6):1337-43. doi: 10.1016/j.jaci.2008.01.022. Epub 2008 Mar 7.
Akdis CA, Akdis M, Bieber T, Bindslev-Jensen C, Boguniewicz M, Eigenmann P, Hamid Q, Kapp A, Leung DY, Lipozencic J, Luger TA, Muraro A, Novak N, Platts-Mills TA, Rosenwasser L, Scheynius A, Simons FE, Spergel J, Turjanmaa K, Wahn U, Weidinger S, Werfel T, Zuberbier T; European Academy of Allergology and Clinical Immunology/American Academy of Allergy, Asthma and Immunology. Diagnosis and treatment of atopic dermatitis in children and adults: European Academy of Allergology and Clinical Immunology/American Academy of Allergy, Asthma and Immunology/PRACTALL Consensus Report. J Allergy Clin Immunol. 2006 Jul;118(1):152-69. doi: 10.1016/j.jaci.2006.03.045.
Sator PG, Schmidt JB, Honigsmann H. Comparison of epidermal hydration and skin surface lipids in healthy individuals and in patients with atopic dermatitis. J Am Acad Dermatol. 2003 Mar;48(3):352-8. doi: 10.1067/mjd.2003.105.
Cork MJ, Robinson DA, Vasilopoulos Y, Ferguson A, Moustafa M, MacGowan A, Duff GW, Ward SJ, Tazi-Ahnini R. New perspectives on epidermal barrier dysfunction in atopic dermatitis: gene-environment interactions. J Allergy Clin Immunol. 2006 Jul;118(1):3-21; quiz 22-3. doi: 10.1016/j.jaci.2006.04.042. Epub 2006 Jun 9.
Werner Y, Lindberg M. Transepidermal water loss in dry and clinically normal skin in patients with atopic dermatitis. Acta Derm Venereol. 1985;65(2):102-5.
Chandar P, Nole G, Johnson AW. Understanding natural moisturizing mechanisms: implications for moisturizer technology. Cutis. 2009 Jul;84(1 Suppl):2-15.
O'Regan GM, Sandilands A, McLean WHI, Irvine AD. Filaggrin in atopic dermatitis. J Allergy Clin Immunol. 2008 Oct;122(4):689-693. doi: 10.1016/j.jaci.2008.08.002. Epub 2008 Sep 5.
McLean WH, Palmer CN, Henderson J, Kabesch M, Weidinger S, Irvine AD. Filaggrin variants confer susceptibility to asthma. J Allergy Clin Immunol. 2008 May;121(5):1294-5; author reply 1295-6. doi: 10.1016/j.jaci.2008.02.039. Epub 2008 Apr 8. No abstract available.
Tilles G, Wallach D, Taieb A. Topical therapy of atopic dermatitis: controversies from Hippocrates to topical immunomodulators. J Am Acad Dermatol. 2007 Feb;56(2):295-301. doi: 10.1016/j.jaad.2006.09.030.
Burkhart CG. Clinical assessment by atopic dermatitis patients of response to reduced soap bathing: pilot study. Int J Dermatol. 2008 Nov;47(11):1216-7. doi: 10.1111/j.1365-4632.2008.03829.x. No abstract available.
Hanifin JM, Tofte SJ. Update on therapy of atopic dermatitis. J Allergy Clin Immunol. 1999 Sep;104(3 Pt 2):S123-5. doi: 10.1016/s0091-6749(99)70054-0.
Tarr A, Iheanacho I. Should we use bath emollients for atopic eczema? BMJ. 2009 Nov 13;339:b4273. doi: 10.1136/bmj.b4273. No abstract available.
Gutman AB, Kligman AM, Sciacca J, James WD. Soak and smear: a standard technique revisited. Arch Dermatol. 2005 Dec;141(12):1556-9. doi: 10.1001/archderm.141.12.1556.
Chiang C, Eichenfield LF. Quantitative assessment of combination bathing and moisturizing regimens on skin hydration in atopic dermatitis. Pediatr Dermatol. 2009 May-Jun;26(3):273-8. doi: 10.1111/j.1525-1470.2009.00911.x.
Kameyoshi Y, Tanaka T, Mochizuki M, Koro O, Mihara S, Hiragun T, Tanaka M, Hide M. [Taking showers at school is beneficial for children with severer atopic dermatitis]. Arerugi. 2008 Feb;57(2):130-7. Japanese.
Mochizuki H, Muramatsu R, Tadaki H, Mizuno T, Arakawa H, Morikawa A. Effects of skin care with shower therapy on children with atopic dermatitis in elementary schools. Pediatr Dermatol. 2009 Mar-Apr;26(2):223-5. doi: 10.1111/j.1525-1470.2009.00887.x.
Cardona ID, Cho SH, Leung DY. Role of bacterial superantigens in atopic dermatitis : implications for future therapeutic strategies. Am J Clin Dermatol. 2006;7(5):273-9. doi: 10.2165/00128071-200607050-00001.
Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Pediatrics. 2009 May;123(5):e808-14. doi: 10.1542/peds.2008-2217.
Breneman DL, Hanifin JM, Berge CA, Keswick BH, Neumann PB. The effect of antibacterial soap with 1.5% triclocarban on Staphylococcus aureus in patients with atopic dermatitis. Cutis. 2000 Oct;66(4):296-300.
Kubota K, Machida I, Tamura K, Take H, Kurabayashi H, Akiba T, Tamura J. Treatment of refractory cases of atopic dermatitis with acidic hot-spring bathing. Acta Derm Venereol. 1997 Nov;77(6):452-4. doi: 10.2340/0001555577452454.
Murota H, Takahashi A, Nishioka M, Matsui S, Terao M, Kitaba S, Katayama I. Showering reduces atopic dermatitis in elementary school students. Eur J Dermatol. 2010 May-Jun;20(3):410-1. doi: 10.1684/ejd.2010.0928. Epub 2010 Apr 23. No abstract available.
Schuttelaar ML, Coenraads PJ. A randomized, double-blind study to assess the efficacy of addition of tetracycline to triamcinolone acetonide in the treatment of moderate to severe atopic dermatitis. J Eur Acad Dermatol Venereol. 2008 Sep;22(9):1076-82. doi: 10.1111/j.1468-3083.2008.02716.x. Epub 2008 Apr 1.
Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. doi: 10.1159/000247298.
Carel K, Bratton DL, Miyazawa N, Gyorkos E, Kelsay K, Bender B, Strand M, Atkins D, Gelfand EW, Klinnert MD. The Atopic Dermatitis Quickscore (ADQ): validation of a new parent-administered atopic dermatitis scoring tool. Ann Allergy Asthma Immunol. 2008 Nov;101(5):500-7. doi: 10.1016/S1081-1206(10)60289-X.
Lewis-Jones MS, Finlay AY, Dykes PJ. The Infants' Dermatitis Quality of Life Index. Br J Dermatol. 2001 Jan;144(1):104-10. doi: 10.1046/j.1365-2133.2001.03960.x.
27. Hanifin JM, Rajka G. Diagnostic features of atopic derma titis. Acta Derm Venereol1980;92:44-7.
Woo SI, Kim JY, Lee YJ, Kim NS, Hahn YS. Effect of Lactobacillus sakei supplementation in children with atopic eczema-dermatitis syndrome. Ann Allergy Asthma Immunol. 2010 Apr;104(4):343-8. doi: 10.1016/j.anai.2010.01.020.
Gruber C, Wendt M, Sulser C, Lau S, Kulig M, Wahn U, Werfel T, Niggemann B. Randomized, placebo-controlled trial of Lactobacillus rhamnosus GG as treatment of atopic dermatitis in infancy. Allergy. 2007 Nov;62(11):1270-6. doi: 10.1111/j.1398-9995.2007.01543.x.
Meggitt SJ, Gray JC, Reynolds NJ. Azathioprine dosed by thiopurine methyltransferase activity for moderate-to-severe atopic eczema: a double-blind, randomised controlled trial. Lancet. 2006 Mar 11;367(9513):839-46. doi: 10.1016/S0140-6736(06)68340-2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3927
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.