Phase 3
Completed N=303
A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis
dermatitis · Atopic
Source: ClinicalTrials.gov NCT01840605 ↗
Enrolled (actual)
303
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcomePrimary: Change From Baseline in Pruritus Score — -0.669; -0.638 units on a scale
Summary
The objective of this study is to verify the non-inferiority of TAU-284 to ketotifen fumarate dry syrup in the change in the severity of pruritus after the treatment period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pruritus Score |
-0.425; -0.510 | — |
| SECONDARY Change From Baseline in Pruritus Score |
-0.425; -0.510 | — |
| SECONDARY Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline) |
-0.8; -0.7 | — |
| SECONDARY Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus) |
65.6; 65.1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients aged between 7 and 15 years
- Patients giving assent and whose legal guardian giving informed consent
- Outpatients
- Patients diagnosed as atopic dermatitis
- Patients who require the treatment with topical corticosteroid on areas other than face, head and neck
- Patients whose diaries can be properly maintained
- Patients who have 2 grades or more pruritus score
Exclusion Criteria
- Patients with bronchial asthma who require concomitant use of the corticosteroid
- Patients who have been undergoing specific desensitization therapy or nonspecific immunomodulation therapy or phototherapy
- Patients with current or previous history of drug hypersensitivity
- Patients who have been treated with Bepotastine besilate in the past
- Patients who have; a skin infection, or with zooparasite such as scabies and pediculosis; eczematous otitis externa with perforation in the eardrum; dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2; on areas where topical corticosteroid is applied
- Patients who have spastic disease such as epilepsy
- Patients who concurrently have renal function abnormalities that may cause safety problems
- Patients who do not give consent to use birth control
- Pregnant patients, at risk of pregnancy or breastfeeding
- Patients who had participated in any clinical trial in the last 12 weeks
Data sourced from ClinicalTrials.gov (NCT01840605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.