"ELAN" Une étude randomisée, en double aveugle, unicentrique et controllée comparant l’efficacité, la sécurité et la tolérance de la solution cutanée CG 428 versus un placebo chez des patientes traitées pour une chimiothérapie alopéciante

Drug: CG 428 cutaneous solution;Drug: Placebo cutaneous solution

Inclusion Criteria:

- Adult female, age = 18 years.

- Patient with cancer, requiring one of the following pre-specified chemotherapy regimen
according to local guidelines: weekly paclitaxel, weekly docetaxel, eribuline or
associationof 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.

- 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.