An open label, 52 week, multicenter study, of long term management to evaluate effectiveness, tolerability and safety of pimecrolimus cream 1% in pediatric patients with mild to moderate atopic dermatitis in a daily practice

• Register: EUCTR
• Last refreshed on: 2 October 2017
• Main ID: EUCTR2017-001766-25-Outside-EU/EEA
• Date of registration: 28/09/2017
• Prospective Registration: Yes
• Primary sponsor: Novartis
• Public title: An open label, 52 week, multicenter study, of long term management to evaluate effectiveness, tolerability and safety of pimecrolimus cream 1% in pediatric patients with mild to moderate atopic dermatitis in a daily practice
• Scientific title: An open label, 52 week, multicenter study, of long term management to evaluate effectiveness, tolerability and safety of pimecrolimus cream 1% in pediatric patients with mild to moderate atopic dermatitis in a daily practice
• Target sample size: 179
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001766-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Mexico, Venezuela, Bolivarian Republic of

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion 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:
•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.).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

mild to moderate atopic dermatitis

Intervention(s)

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: PIMECROLIMUS
Concentration unit: % percent
Concentration type: equal
Concentration number: 1-

Primary Outcome(s)

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

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)

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.

Timepoint(s) of evaluation of this end point: 52 weeks

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 52 weeks

Secondary end point(s): Efficacy:(Secondary)
o IGA assessment
o F-IGA assessment
o Subject’s overall satisfaction

Secondary ID(s)

CASM981CVE01

Source(s) of Monetary Support

Novartis