Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119158
Status:
COMPLETED
Last Update Posted:
2010-07-27
First Post:
2005-07-05
Brief Title:
Combination Therapy for Atopic Dermatitis
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
An Exploratory Double-blind Randomized Vehicle-controlled Paired Study to Evaluate the Efficacy and Safety of Concomitant Use of Elidel Cream 1 and Cutivate Cream 005 in Patients With Severe Lesions of Atopic Dermatitis AD
Status:
COMPLETED
Status Verified Date:
2010-07
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:
None
Brief Summary:
Atopic dermatitis is a chronic relapsing disease with acute flares The standard therapy is to treat acute flares using topical medications The two most common classes of topical medications for atopic dermatitis AD are topical corticosteroids and topical calcineurin inhibitors
Pimecrolimus and topical corticosteroids exert their activity by different mechanisms there may be a synergistic effect of the combination therapy Therefore a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance
The hypothesis of this trial is that the combination of the two agents will lead to faster clearance than the single agent of topical corticosteroids
Pimecrolimus and topical corticosteroids exert their activity by different mechanisms there may be a synergistic effect of the combination therapy Therefore a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance
The hypothesis of this trial is that the combination of the two agents will lead to faster clearance than the single agent of topical corticosteroids
Detailed Description:
This trial is a double-blind controlled trial of fluticasone cream daily and pimecrolimus cream BID versus fluticasone cream daily and placebo cream BID for the treatment of acute flares of atopic dermatitis
While pimecrolimus cream 1 has been proven to be effective in mild and moderate Atopic dermatitis AD there is a need for a fast control of severe skin lesions On the other hand reducing the duration of the topical corticosteroid treatment is a reasonable approach to minimize the occurrence of adverse effects
Because pimecrolimus and topical corticosteroids exert their activity by different mechanisms there may be a synergistic effect of the combination therapy Therefore a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance
In vitro data have demonstrated that a combination of steroids and tacrolimus has synergistic effects on in vitro human lymphocyte proliferation In addition it has previously been reported in a pilot investigation in two subjects that a combination regimen of pimecrolimus 1 twice a day and fluticasone propionate cream 005 once daily was superior to fluticasone propionate cream 005 once daily in the acute treatment of atopic dermatitis AD
This study is conducted to validate these findings in a larger number of patients
While pimecrolimus cream 1 has been proven to be effective in mild and moderate Atopic dermatitis AD there is a need for a fast control of severe skin lesions On the other hand reducing the duration of the topical corticosteroid treatment is a reasonable approach to minimize the occurrence of adverse effects
Because pimecrolimus and topical corticosteroids exert their activity by different mechanisms there may be a synergistic effect of the combination therapy Therefore a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance
In vitro data have demonstrated that a combination of steroids and tacrolimus has synergistic effects on in vitro human lymphocyte proliferation In addition it has previously been reported in a pilot investigation in two subjects that a combination regimen of pimecrolimus 1 twice a day and fluticasone propionate cream 005 once daily was superior to fluticasone propionate cream 005 once daily in the acute treatment of atopic dermatitis AD
This study is conducted to validate these findings in a larger number of patients
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