Multicentre, 16 week study divided into a randomized, double-blind, placebo controlled, parallel group phase lasting 4 weeks, and a 12 week, follow-up phase to evaluate the safty of pimecrolimus 1% cream BID in addition to topical steroids in the treatment of severe atopic dermatitis in 2 -17 year old patients.
| DEC-NET Serial number IT430 | |
| Published online | 27/06/2005 10.23.00 |
| Last updated | 11/08/2006 16.20.26 |
| Other protocol ID number | CASM981C2439 |
| Current trial status | Open (actively recruiting new participants) |
| Major Disease (ICD9 class) | Atopic dermatitis and related conditions |
| Experimental drug | |
| pimecrolimus | |
| Gender | Both |
| Age (range) | 2-17 years |
Eligibility criteria | |
| Inclusion criteria | |
| - Written informed consent - Atopic dermatitis diagnosis according to Williams criteria - Atopic dermatitis involving more than or equal to 5% of body surface excluding face - Severe atopic dermatitis, defined by IGA score of greater than or equal to 4. | |
| Exclusion criteria | |
| - Pregnancy or breastfeeding. Women of childbearing age must take an approved contraceptive throughout the study period and for 4 weeks afterwards - Concomittant cutaneous disease (eg acne) in the same area as the dermatitis to be studied - Bacterial, viral, or fungal cutaneous infections in the same areas where dermatitis is present and that will be treated - Immune system diseases (lymphoma, AIDS, Wiskott-Aldrich syndrome) or cancer - Significant atopic dermatitis - Scarse or no clinical response to previous treatment with topical tacrolimus or pimecrolimus cream - Phototherapy or systemic therapies - Treatment with systemic corticosteroids in the 4 weeks prior to initiation of the study.s drug therapy - Topical treatment with tacrolimus ointment of pimecrolimus cream in the preceding 4 weeks. - Topical therapy known to have a therapeutic effect on dermatitis in the 4 days prior to initiation of the study.s drug therapy - ... | |
Trial design/methodology | |
| Phase | 3 |
| Kind of study | Efficacy Safety |
| Design | Controlled Randomised Blinded Double blind Gruppi paralleli |
| Purpose of study | |
| - To evaluate the safety of pimecrolimus cream 1% and topical steroid association compared to topical steroid used alone in treating severe atopic dermatitis in 2-17 year old patients. - To document the safety of the association compared to topical steroid alone in terms of adverse reaction indicence during treatment. - Explore the efficacy of the association compared topical steroid used alone with respect to: 1) time to relapse; 2) time needed to achieve therapeutic success; 3) number of patients who achieve therapeutic success; 4)improvement in EASI (Eczema Area Severity Index); 5)itch relief. - Explore treatment effects on quality of life of patients and their families. | |
| Principal investigator | |
| Name | Dr. Corrado Occella |
| Institution | Istituto G. Gaslini |
| Postal address | Largo G. Gaslini, 5 |
| City | Genova |
| Country | ITALY |
| Phone | 010 - 5636352 |
| Fax | |
| corradooccella@ospedale-gaslini.ge.it | |
| Sponsor name |
| Novartis Farma spa (Industry) |
| Participating countries |
| CANADA |
| SOUTH AFRICA |
| ITALY |
| UNITED STATES |
| Participating centres |
| Policlinico S. Matteo - IRCCS - Divisione di Clinica Pediatrica (Pavia (PV)) |
| Azienda Policlinico - Cattedra Pediatria Preventiva e Sociale Clinica Pediatrica I (Catania (CT)) |
| Istituto Giannina Gaslini - U.O.C. Pneumologia (Genova Quarto (GE)) |
| Università degli Studi - Istituto di Scienze Dermatologiche (Milano (MI)) |
| Az.Osp. Ospedale Consorziale e Policlinico - Clinica Dermatologica II (Bari (BA)) |
| Ospedale Anna Meyer - Clinica Pediatrica III (Firenze (FI)) |
| Presd. Osp. Macedonio Melloni - Divisione di Pediatria (Milano (MI)) |
| II Università di Napoli - Serv.Auton. Asma e Fisiopatologia Resp. Infantile Maurizio Miraglia del Giudice Dip. di Pediatria (Napoli (NA)) |
| ISRCTN | EudraCT |
