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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00910676

Acronym

DIPROCOL

Enrollment

Registered

2009-06-01

Start date

2007-10-31

Completion date

2009-03-31

Last updated

2012-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer, Non-Small-Cell Lung Carcinoma

Keywords

EGF-R inhibitors

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.

Interventions

DRUGDiprosone

* 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026