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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00910676
Other study ID # 2007-002913-38
Secondary ID
Status Completed
Phase Phase 2
First received May 29, 2009
Last updated July 30, 2012
Start date October 2007
Est. completion date March 2009

Study information

Verified date July 2012
Source Centre Oscar Lambret
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

Patients will receive local prophylactic treatment (Diprosone cream) during 8 weeks from the beginning of the EGF-R inhibitors treatment, on the areas of the body susceptible to be affected by folliculitis.


Other known NCT identifiers
  • NCT00960388

Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 least one chemotherapy treatment

- No pre-existing cutaneous toxicity

Exclusion Criteria:

- Contraindication to local corticotherapy

- Previous history of severe hypersensibility reactions (Grade III or IV) due to Cetuximab, Irinotecan or Erlotinib

- Betamethasone or one of excipient product allergy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Drug:
Diprosone
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

Locations

Country Name City State
France Centre Hospitalier Regional Lille
France Centre Hospitalier Régional Lille
France Centre Oscar Lambret Lille

Sponsors (2)

Lead Sponsor Collaborator
Centre Oscar Lambret Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary To assess the frequency of grade I, II and III folliculitis under Cetuximab and under Erlotinib 2 months of treatment No
Secondary To list the cutaneous side effects of the EGF-R inhibitors 2 months of treatment Yes
Secondary To assess the patient quality of life with the DLQI questionnaire 2 months of treatment No
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