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

Sponsor

Legacy Healthcare SA (Industry)

Overall Status

Completed

CT.gov ID

NCT02919735

Collaborator

(none)

Enrollment

Location

Arms

28.9

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase II clinical trial

Condition or Disease	Intervention/Treatment	Phase
Alopecia	Drug: CG 428 cutaneous solution Drug: Placebo cutaneous solution	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Mar 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.