Appendix ZOOM Etude pour site internet Inclusion criteria

Département d’oncologie
Centre de Thérapies Expérimentales
Unité d’Investigation Clinique (UIC)
Doc Nr: UIC-MOP-APP-023
ZOOM Etude pour site Internet
Appendix
ZOOM Etude pour site internet
Indication
Title
Crème topique pour la repousse des cheveux
A Randomized, Double Blind, Single center, Controlled Study to
Compare the Efficacy, Safety and Tolerability of CG 428 cutaneous
solution with Placebo on Alopecia in Cancer female Patients under
Chemotherapy. “ELAN”
Protocol ID
ELAN
Phase
II
Sponsor
Legacy Healthcare
Principal
Investigator
Dr. K. Zaman
Primary Objective
The aim of this trial is to compare the degree of efficacy, safety and
tolerability of CG 428 cutaneous solution versus placebo on prevention
of chemotherapy induced alopecia (CIA) in female patients with
metastatic cancer treated with selected regimens inducing alopecia.
Inclusion/exclusion
criteria
Inclusion criteria
Adult female, age ≥ 18 years
Advanced stage cancer, requiring one of the following pre-specified
chemotherapy regimen according to local guidelines: weekly paclitaxel,
weekly
docetaxel,
eribuline
or
association
of
weekly
paclitaxel/docetaxel with carboplatine (association of targeted therapies
not influencing significantly the risk of alopecia is allowed, i.e.
trastuzumab, pertuzumab or bevacizumab).
Healthy hair (no current alopecia or scalp disease treatment).
Life expectancy ≥ 6 months.
Able to use the study treatment in compliance with the protocol.
Physical and psychological ability to participate
Negative serum pregnancy test within 14 days prior to randomization
in premenopausal women with childbearing potential.
Patients must agree to not shave their head (minimum ≥ 1 cm).
Signed and dated informed consent.
Exclusion criteria
Other ongoing anti-neoplastic therapy or other investigational drug
with potential effect on hair growth.
Patients treated with proteasome inhibitors, i.e. bortezomib
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Département d’oncologie
Centre de Thérapies Expérimentales
Unité d’Investigation Clinique (UIC)
Doc Nr: UIC-MOP-APP-023
ZOOM Etude pour site Internet
Prior radiotherapy to the scalp with residual alopecia
Known allergy or hypersensitivity to some components of CG 428
cutaneous solution (including allium cepa (onion), citrus, caffeine,
theobromine)
Pre-existing alopecia or significant scalp disease, which may alter
study treatment administration or absorption.
Concomitant use of cold cap or any other anti-hair loss treatment.
Hair transplants.
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