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Diprosone

Phase 2FDA approved

Metastatic Colorectal Cancer | Small molecule | Other |Roche Holding AG|Trials Updated: Jul 31, 2012

Diprosone development status

FDA approval on record Oct 3, 2001
Approval holderSchering
ApplicationNDA017691
Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jun 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Diprosone clinical trials

Diprosone · 1 trial · 2 indications

Phase 2 1
NCT00910676Study About Preventive Treatment of Folliculitis Induced by Epidermal Growth Factor Receptor InhibitorsMetastatic Colorectal Cancer
COMPLETED30 Analytics
PHASE2COMPLETED
Study About Preventive Treatment of Folliculitis Induced by Epidermal Growth Factor Receptor Inhibitors
Metastatic Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To reduce by 30 % the frequency of folliculitis by a local corticotherapy beginning at the same time that the treatment by EGF-R inhibitors began
2 months of treatment by corticotherapy

Secondary Endpoints

To assess the frequency of grade I, II and III folliculitis under Cetuximab and under Erlotinib
2 months of treatment
To list the cutaneous side effects of the EGF-R inhibitors
2 months of treatment
To assess the patient quality of life with the DLQI questionnaire
2 months of treatment
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
DIPROSONEEXPERIMENTAL -

Interventions

NameTypeDescription
DiprosoneDRUG* Start of treatment: as soon as the EGF-R inhibitors treatment begins * Application: On the body area susceptible to be affected by folliculitis, once a day, in the evening * Dosage: Quantity corresponded to around 2 tubes of 30 grams a week on the face, the chest and upper side of the back. There is no maximum dosage. * Period of treatment: 8 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Indication of Cetuximab in patients with metastatic colorectal cancer in association or not with irinotecan, after failure of a chemotherapy treatment with Irinotecan OR * Indication of Erlotinib, in patients with metastatic Non-Small-Cell Lung Carcinoma, after failure of at l...

Countries:France
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Competitive Landscape -Colorectal Cancer 366 trials (matched to "Metastatic Colorectal Cancer")

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