Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT02919735
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02919735
Study Brief:
Protocol Section:
NCT02919735