Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00507832
Status:
COMPLETED
Last Update Posted:
2010-07-07
First Post:
2007-07-26
Brief Title:
Evaluation of the Antipruritic Effect of Elidel Pimecrolimus in Non-atopic Pruritic Disease
Sponsor:
University Hospital Muenster
Organization:
University Hospital Muenster
Study Overview
Official Title:
Evaluation of the Antipruritic Effect of Elidel Pimecrolimus in Non-atopic Pruritic Disease
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASM981CDE21
Brief Summary:
The development of the topical calcineurin inhibitor pimecrolimus resulted in a significant improvement in the treatment of atopic dermatitis In addition an excellent amelioration of pruritus could be regularly observed Up to now several itchy dermatoses such as chronic irritative hand dermatitis rosacea graft-versus-host-disease lichen sclerosus prurigo simplex scrotal eczema and inverse psoriasis were reported as single cases also to respond to a pimecrolimus treatment
In prurigo nodularis pruritus is the main symptom and it is of immediate importance to find an effective antipruritic therapy Pruritus is regularly severe and therapy refractory to topical steroids or systemic antihistamines Capsaicin cream is one effective possibility to reduce the itch in these diseases However it has to be applied 3 to 6 times daily rubs off on the clothing and induces burning in erosions In addition since no commercial preparation is available it has to be prescribed in several concentrations The application of pimecrolimus seems to be promising since it has to be applied twice daily only Especially in prurigo nodularis we expect a good response as we could demonstrate in single patients Furthermore it has been published recently that Tacrolimus another calcineurin inhibitor has been successfully used in the treatment of six patients with prurigo nodularis
This study is designed to compare the efficacy and safety of pimecrolimus 1 cream and hydrocortisone 1 cream in prurigo nodularis and to investigate the mode of action of the antipruritic effect of the drugs
In prurigo nodularis pruritus is the main symptom and it is of immediate importance to find an effective antipruritic therapy Pruritus is regularly severe and therapy refractory to topical steroids or systemic antihistamines Capsaicin cream is one effective possibility to reduce the itch in these diseases However it has to be applied 3 to 6 times daily rubs off on the clothing and induces burning in erosions In addition since no commercial preparation is available it has to be prescribed in several concentrations The application of pimecrolimus seems to be promising since it has to be applied twice daily only Especially in prurigo nodularis we expect a good response as we could demonstrate in single patients Furthermore it has been published recently that Tacrolimus another calcineurin inhibitor has been successfully used in the treatment of six patients with prurigo nodularis
This study is designed to compare the efficacy and safety of pimecrolimus 1 cream and hydrocortisone 1 cream in prurigo nodularis and to investigate the mode of action of the antipruritic effect of the drugs
Detailed Description:
Patients will be treated with pimecrolimus cream 1 and hydrocortisone cream 1 twice daily for 8 weeks on diseased skin in a double-blind randomized within patient comparison left arm pimecrolimus right arm hydrocortisone or vice versa Patients will then enter a 4-week treatment free follow-up period The overall study duration is 12 months
The study population will consist of a representative group of 30 adult patients 18 - 70 years of age with prurigo nodularis from one center in Germany
Inclusion criteria
Age 18 - 70 years
Diagnosis Prurigo nodularis
Pruritus intensity above VAS 3 Visual analogue scale 0 to 10
Nodules on arms and legs target areas arms
No effective current external or internal antipruritic medication
Signed informed consent
Exclusion criteria
prurigo nodularis with massive excoriations andor local infections
atopic dermatitis predisposition for atopic dermatitis
Itch intensity below VAS 4 visual analoge scale 0 to 10
Pregnant or nursing lactating women where pregnancy is defined as the state of a female after conception and until the termination of gestation confirmed by a positive hCG test Pregnancy should be ruled out before stating the study by a b-subunit HCG test
Females of childbearing potential and not practicing a medically approved highly effective low failure rate method of contraception during and up to at least 4 weeks after the end of treatment Medically approved contraception may include implants injectables combined oral contraceptives some IUDs eg intrauterine device sexual abstinence or if the woman has a vasectomized partner
active psychosomatic and psychiatric diseases
History of active malignancy of any organ system
actual diseases which need therapy and may induce pruritus eg deficiency of iron zinc
Systemic immunosuppression
Topical use of tacrolimus pimecrolimus steroids or capsaicin within 2 weeks prior to study entry
current and past within 2 weeks prior to study entry systemic use of antihistamines steroids cyclosporin A and other immunosuppressants paroxetin fluvoxamine selective serotonin reuptake- inhibitors study possible in case of medication since 6 months due to depression without having any Antipruritic effect naltrexone and UV-therapy
wound healing disturbances disposition for keloids current medication which leads to increased bleeding during procedure eg acetylsalicylic acid ASS marcumar no suction blister possible
History of hypersensitivity to pimecrolimus 1 cream or hydrocortisone 1 cream
Participation in other clinical studies within the last 4 weeks
The study population will consist of a representative group of 30 adult patients 18 - 70 years of age with prurigo nodularis from one center in Germany
Inclusion criteria
Age 18 - 70 years
Diagnosis Prurigo nodularis
Pruritus intensity above VAS 3 Visual analogue scale 0 to 10
Nodules on arms and legs target areas arms
No effective current external or internal antipruritic medication
Signed informed consent
Exclusion criteria
prurigo nodularis with massive excoriations andor local infections
atopic dermatitis predisposition for atopic dermatitis
Itch intensity below VAS 4 visual analoge scale 0 to 10
Pregnant or nursing lactating women where pregnancy is defined as the state of a female after conception and until the termination of gestation confirmed by a positive hCG test Pregnancy should be ruled out before stating the study by a b-subunit HCG test
Females of childbearing potential and not practicing a medically approved highly effective low failure rate method of contraception during and up to at least 4 weeks after the end of treatment Medically approved contraception may include implants injectables combined oral contraceptives some IUDs eg intrauterine device sexual abstinence or if the woman has a vasectomized partner
active psychosomatic and psychiatric diseases
History of active malignancy of any organ system
actual diseases which need therapy and may induce pruritus eg deficiency of iron zinc
Systemic immunosuppression
Topical use of tacrolimus pimecrolimus steroids or capsaicin within 2 weeks prior to study entry
current and past within 2 weeks prior to study entry systemic use of antihistamines steroids cyclosporin A and other immunosuppressants paroxetin fluvoxamine selective serotonin reuptake- inhibitors study possible in case of medication since 6 months due to depression without having any Antipruritic effect naltrexone and UV-therapy
wound healing disturbances disposition for keloids current medication which leads to increased bleeding during procedure eg acetylsalicylic acid ASS marcumar no suction blister possible
History of hypersensitivity to pimecrolimus 1 cream or hydrocortisone 1 cream
Participation in other clinical studies within the last 4 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None