A randomized, open-label, parallel group study to evaluate the efficacy and safety of proactive management in pediatric subjects with moderate to severe atopic dermatitis
- Conditions
- atopic dermatitis
- Registration Number
- JPRN-UMIN000005536
- Lead Sponsor
- Division of Allergy, Department of Medical Specialties, National Center for Child Health and Development
- Brief Summary
Abstract Proactive therapy for atopic dermatitis (AD) effectively prevents exacerbation. However, its role in preventing subsequent sensitization to allergens has not been prospectively studied. We investigated whether proactive therapy for AD can effectively impact immunological parameters in a randomized, investigator-blinded, parallel group study. Thirty patients aged 3 months to 7 years with moderate to severe AD who had undergone an AD educational program were allocated to a proactive treatment group or a reactive treatment group. During the disease control period, patients in the proactive group performed intermittent preventive application of topical corticosteroid for 1 year. Changes in the severity scoring, quality of life measures and immunological parameters (serum thymus and activation regulated chemokine [TARC], total immunoglobulin E [IgE] and house dust mite-specific IgE levels) were evaluated and compared between the proactive and reactive treatment groups. Although the average topical corticosteroid ointment use per day in both groups was not significantly different, the severity and quality of life scores were significantly lower in the proactive group than in the reactive group at the final visit. In addition, compared with baseline levels, serum TARC levels remained significantly lower during proactive therapy, while house dust mite-specific IgE levels were significantly increased only in the reactive group. The results suggest that in addition to controlling the severity of AD, intermittent preventive administration of topical corticosteroids may prevent an increase in aeroallergen-specific IgE levels in patients with childhood AD. The use of TARC levels as a biomarker for AD remission is also supported.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
The exclusion criteria is as followed; (1) The patients receiving any additional systemic therapies included corticosteroids, nonsteroidal immunosuppressive agents or biological immunotherapy, (2) the patients who has a past history of cardiovascular disease, liver dysfunction, kidney disease and other current serious medical problems.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with SCORAD < 20 and SCORAD <50 at each study visit [Time Frame: 24 months]
- Secondary Outcome Measures
Name Time Method Decrease of total serum IgE after 3, 6, 12 and 24 months of treatment [Time Frame: at 3, 6, 12 and 24 months] Change of immunological parameters (blood eosinophil count, TARC, specific IgE, IL-4, IL-5, IL-13, IL-17, IL-33, IFN-gamma) [Time Frame: at 3, 6, 12 and 24 months] Quality of life (Children's dermatology life quality index and the dermatitis family impact questionnaire) at 6, 12 and 24 months. Intensity of pruritus at each day as reported in the patient's diary by means of visual analogue scale (VAS) Change of serum and salivary cortisol level at 6, 12 and 24 months [Time Frame: at 6, 12 and 24 months] Local side effects on the skin, and incidence and severity of adverse event at each study visit [Time Frame: 24 months]