mild to moderate atopic dermatitis
Conditions
Interventions
Trade Name: Elidel
Product Name: Elidel
Product Code: ASM981
Pharmaceutical Form: Cream
INN or Proposed INN: Pimecrolimus
CAS Number: 137071-32-0
Current Sponsor code: ASM981
Other descriptive name:
Sponsors
Novartis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Pediatric outpatients, male or female, age 3 months to 12 years old, with mild to moderate atopic dermatitis. •Investigators Global Assessment (IGA) = 1 •Written inform consent Are the trial subjects under 18? yes Number of subjects for this age range: 179 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Concurrent diseases/conditions and history of other diseases/conditions •Subjects who have active viral infections at the treatment site. •Subjects who present with systemic malignancy or active lymphoproliferative diseases/disorders (e.g., lymphoma, neoplastic disease, chronic lymphoproliferation). •Subjects who present with clinical conditions other than AD that can interfere with the evaluation (e.g., generalized erythroderma such as the genetic condition, Netherton’s Syndrome, other skin conditions such as psoriasis, or skin malignancies such as squamous cell or basal cell carcinoma - please note that this does not exclude subjects who have a history of skin malignancies which have been previously treated, are in complete remission, and who are expected to be medically stable during the 12-month study period.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effectiveness of pimecrolimus cream 1% in the long-term management in mild to moderate atopic dermatitis in pediatric patients in a daily practice;Secondary Objective: •To monitor the safety of pimecrolimus cream 1% in the long-term management • To evaluate quality of life of both parent and patient assessed by questionnaire. ;Primary end point(s): Efficacy: (Primary) Number of days of TCS usage Safety: Safety assessments will consist of monitoring and recording all adverse events and serious adverse events, and the performance of a physical examination. Quality of life: According to the Parent’s Index of Quality of Life Questionnaire -Atopic Dermatitis (PIQoL-AD) and the Children’s Dermatological Life Quality Index (CDLQI) ;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy:(Secondary) o IGA assessment o F-IGA assessment o Subject’s overall satisfaction ;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Countries
Mexico, Venezuela, Bolivarian Republic of
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed