Efficacy, Safety and Tolerability of CG428 Cutaneous Solution on Chemotherapy Induced Alopecia; Controlled Study (ELAN)

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

Phase II clinical trial

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Legacy Healthcare SA
• Treatments: Pharmaceutical Solutions

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.