Clinical trial NCT02919735: Efficacy, Safety and Tolerability of CG428 Cutaneous Solution on Chemotherapy Induced Alopecia; Controlled Study (ELAN)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alopecia
Keywords: Alopecia
Hair
Chemotherapy
Cancer
Lead sponsor: Legacy Healthcare SA
Sponsor class: INDUSTRY
First posted: 2016-09-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Phase II clinical trial

Detailed description: 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.

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.

Primary outcomes:
measure: Rate of hair loss at different time points based of on Olsen's Visual Analog Scale (OVAS) and using the Severity of Alopecia Tool score (SALT score)
timeFrame: Every 3 to 8 weeks (variable). The following investigations will be performed every 3 to 4 weeks during the study treatment
Secondary outcomes:
measure: Rate of grade 2 alopecia according to CTCAE v. 4.03.
timeFrame: Every 3 weeks for 24 weeks.
measure: Time to reach grade 2 alopecia during chemotherapyaccording to CTCAE v. 4.03. .
timeFrame: Every 3 weeks for 24 weeks.
measure: Time to recover to grade 1 and grade 0 according to CTCAE v. 4.03 after the last dose of the selected chemotherapy
timeFrame: Every 3 weeks for 24 weeks.
measure: Percent of hair loss according to OVAS (Olsen's visual analog scale) at different time points after the end of the chemotherapy.
timeFrame: Every 3 to 8 weeks (variable). The following investigations will be performed every 3 to 4 weeks during the study treatment
measure: Adverse events based on the CTCAE 4.03.
timeFrame: Every 3 to 8 weeks (variable). The following investigations will be performed every 3 to 4 weeks during the study treatment
measure: Patient's subjective assessment through questionnaire
timeFrame: Every 3 weeks for 24 weeks.
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV Lausanne
Study officials:
affiliation: Department Oncology - CHUV, 1011 Lausanne - CH
name: Khalil KZ ZAMAN
role: PRINCIPAL_INVESTIGATOR
References: