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

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

Phase II clinical trial

Study Overview

• Status: Completed
• Conditions: Alopecia
• Intervention / Treatment: Drug: CG 428 cutaneous solution; Drug: Placebo cutaneous solution

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1011
    • CHUV Lausanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CG 428 cutaneous solution; Herbal Medicinal Product, topical use by spray on the scalp	Drug: CG 428 cutaneous solution; The patient will spray treatment 10 times directly to the scalp area, with the cannula, and then gently massage the whole scalp with fingertips, twice a day, spaced out by minimum 4 hours
PLACEBO_COMPARATOR: Placebo cutaneous solution; Placebo, topical use by spray on the scalp	Drug: Placebo cutaneous solution; The patient will spray treatment 10 times directly to the scalp area, with the cannula, and then gently massage the whole scalp with fingertips, twice a day, spaced out by minimum 4 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Physical examination of the scalp: skin AEs, hair status (alopecia graded according to CTCAE v.4.03.)	Every 3 to 8 weeks (variable). The following investigations will be performed every 3 to 4 weeks during the study treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of grade 2 alopecia according to CTCAE v. 4.03.	CTCAE v. 4.03 : Common Toxicity Criteria for Adverse Event (skin toxicity)	Every 3 weeks for 24 weeks.
Time to reach grade 2 alopecia during chemotherapyaccording to CTCAE v. 4.03. .	CTCAE v. 4.03 : Common Toxicity Criteria for Adverse Event (skin toxicity)	Every 3 weeks for 24 weeks.
Time to recover to grade 1 and grade 0 according to CTCAE v. 4.03 after the last dose of the selected chemotherapy	CTCAE v. 4.03 : Common Toxicity Criteria for Adverse Event (skin toxicity)	Every 3 weeks for 24 weeks.
Percent of hair loss according to OVAS (Olsen's visual analog scale) at different time points after the end of the chemotherapy.	Olsen's visual analog scale : visual aid for estimating percentage scalp hair loss.	Every 3 to 8 weeks (variable). The following investigations will be performed every 3 to 4 weeks during the study treatment
Adverse events based on the CTCAE 4.03.		Every 3 to 8 weeks (variable). The following investigations will be performed every 3 to 4 weeks during the study treatment
Patient's subjective assessment through questionnaire		Every 3 weeks for 24 weeks.

Collaborators and Investigators

• Sponsor: Legacy Healthcare SA
• Investigators: Principal Investigator: Khalil KZ ZAMAN, Department Oncology - CHUV, 1011 Lausanne - CH

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): July 1, 2018
• Study Completion (ACTUAL): March 1, 2019

Study Registration Dates

• First Submitted: September 18, 2016
• First Submitted That Met QC Criteria: September 28, 2016
• First Posted (ESTIMATE): September 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Cancer; Chemotherapy; Alopecia; Hair
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Pharmaceutical Solutions
• Other Study ID Numbers: ELAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES