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

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT00910676
First received: May 29, 2009
Last updated: July 30, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Metastatic Colorectal Cancer
Non-Small-Cell Lung Carcinoma
 Drug: Diprosone
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the frequency of grade I, II and III folliculitis under Cetuximab and under Erlotinib [ Time Frame: 2 months of treatment ] [ Designated as safety issue: No ]
  • To list the cutaneous side effects of the EGF-R inhibitors [ Time Frame: 2 months of treatment ] [ Designated as safety issue: Yes ]
  • To assess the patient quality of life with the DLQI questionnaire [ Time Frame: 2 months of treatment ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910676

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

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT00910676     History of Changes
Obsolete Identifiers: NCT00960388
Other Study ID Numbers: 2007-002913-38
Study First Received: May 29, 2009
Last Updated: July 30, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Oscar Lambret:
EGF-R inhibitors

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Folliculitis
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
 Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Hair Diseases
Skin Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013