Study About Preventive Treatment of Folliculitis Induced by Epidermal Growth Factor Receptor Inhibitors (DIPROCOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00910676
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : July 31, 2012
Roche Pharma AG
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Non-Small-Cell Lung Carcinoma Drug: Diprosone Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase II Multicentric Study About Preventive Treatment of Folliculitis Induced by the EGF-R Inhibitors in Patients With Metastatic Colorectal Cancer and Treated by Cetuximab or With Non-small-cell Lung Carcinoma Treated by Erlotinib
Study Start Date : October 2007
Primary Completion Date : March 2009
Study Completion Date : March 2009

Arm Intervention/treatment
Experimental: DIPROSONE 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

Primary Outcome Measures :
  1. 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 [ Time Frame: 2 months of treatment by corticotherapy ]

Secondary Outcome Measures :
  1. To assess the frequency of grade I, II and III folliculitis under Cetuximab and under Erlotinib [ Time Frame: 2 months of treatment ]
  2. To list the cutaneous side effects of the EGF-R inhibitors [ Time Frame: 2 months of treatment ]
  3. To assess the patient quality of life with the DLQI questionnaire [ Time Frame: 2 months of treatment ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00910676

Centre Oscar Lambret
Lille, France, 59020
Centre Hospitalier Regional
Lille, France, 59035
Centre Hospitalier Régional
Lille, France, 59035
Sponsors and Collaborators
Centre Oscar Lambret
Roche Pharma AG
Principal Investigator: Laurent MORTIER, MD Centre Hospitalier Régional et Universitaire de LILLE

Responsible Party: Centre Oscar Lambret Identifier: NCT00910676     History of Changes
Obsolete Identifiers: NCT00960388
Other Study ID Numbers: 2007-002913-38
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: July 31, 2012
Last Verified: July 2012

Keywords provided by Centre Oscar Lambret:
EGF-R inhibitors

Additional relevant MeSH terms:
Colorectal Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Hair Diseases
Skin Diseases
Betamethasone benzoate
Betamethasone Valerate
Betamethasone sodium phosphate