Twice Daily Versus Twice Weekly Soak-and-Seal Baths in Pediatric Atopic Dermatitis

NCT03397979 | Completed

• 1 other identifier: 3927
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

There are few studies evaluating best bathing practices in the management of pediatric atopic dermatitis (AD). Trans-epidermal water loss plays a key role in the pathophysiology of AD. In concert with application of topical corticosteroids (TCS), we sought to investigate whether frequent soaking baths (i.e. twice daily for two weeks), followed immediately by application of an occlusive moisturizer (i.e. soak-and-seal), would be more effective than infrequent soaking baths (i.e. twice weekly for two weeks) in the management of AD.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; bathing; baths

Outcome Measures

Primary Outcomes (1)

• SCORAD (SCORing Atopic Dermatitis eczema severity score)

  SCORAD (which stands for SCORing Atopic Dermatitis eczema severity score) is a validated eczema severity score assessed by the treating physician. The scale ranges from 0-103, with higher numbers correlating with more severe/worse eczema.

  Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion criteria. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in SCORAD from baseline (V2), for visits 3 minus visits 4.

Secondary Outcomes (8)

• ADQ (Atopic Dermatitis Quickscore eczema severity score)

  Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion criteria. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in ADQ from baseline (V2), for visits 3 minus visits 4.

• IDQOL (Infant Dermatitis Quality of life index for under 4 years of age)

  Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion criteria. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in IDQOL from baseline (V2), for visits 3 minus visits 4.

• CDLQI (Children's Dermatology Life Quality Index for 4 years of age and older)

  Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion criteria. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in CDLQI from baseline (V2), for visits 3 minus visits 4.

• DFI (Dermatitis Family Impact questionnaire for QOL measure for 5 and up)

  Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion criteria. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in DFI from baseline (V2), for visits 3 minus visits 4.

• Staphylococcal aureus (S. aureus); relative quantities

  Each subject undergoes 4 visits over 5 weeks. Visit 1 (V1) to establish if subject fulfills inclusion. V2 (baseline) is after a 1 week "run-in". 2 weeks between V2-V3 and V3-V4. Change in S. aureus from baseline (V2), for visits 3 minus visits visits 4.

Study Arms (2)

Infrequent soaking baths

ACTIVE COMPARATOR

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.

Behavioral: Infrequent versus Frequent Soaking Baths

Frequent soaking baths

ACTIVE COMPARATOR

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.

Behavioral: Infrequent versus Frequent Soaking Baths

Interventions

Infrequent versus Frequent Soaking Baths BEHAVIORAL

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.

Also known as: Soak and seal baths, Soak and smear baths

Frequent soaking baths; Infrequent soaking baths

Eligibility Criteria

• Age: 6 Months - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants and children ages 6 months to 11 years of age with moderate to severe atopic dermatitis according to the criteria of Hanifin and Rajka.

You may not qualify if:

• Patients with suspected or established primary immune deficiency, patients receiving systemic corticosteroids, ultraviolet light therapy, immuno-therapeutic agents, and/or anti-infective drugs less than 1 month from the onset of the study.

Sponsors & Collaborators

• MaineHealth: lead

Study Sites (1)

Allergy and Asthma Associates of Maine

Portland, Maine, 04102, United States

Location

Related Publications (30)

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MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ivan D Cardona, M.D.

  Allergy & Asthma Associates of Maine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A single treating physician assessed outcomes and, along with those analyzing the data, was masked to group assignment. In other words, the care provider, investigator, and outcomes assessor were blinded to which bathing arm (twice daily or twice weekly) the study participants were in.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Tufts University School of Medicine

Model Details: Randomized, Single-blinded, Prospective Crossover Controlled Trial

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: January 12, 2018
• Study Start: November 14, 2011
• Primary Completion: April 7, 2016
• Study Completion: March 21, 2017
• Last Updated: January 12, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)