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

NCT ID: NCT02919735

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-03-01

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.

Conditions

Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

CG 428 cutaneous solution

Herbal Medicinal Product, topical use by spray on the scalp

Group Type: EXPERIMENTAL

CG 428 cutaneous solution

Intervention Type: DRUG

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 cutaneous solution

Placebo, topical use by spray on the scalp

Group Type: PLACEBO_COMPARATOR

Placebo cutaneous solution

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Legacy Healthcare SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Khalil KZ ZAMAN

Role: PRINCIPAL_INVESTIGATOR

Department Oncology - CHUV, 1011 Lausanne - CH

Locations

CHUV Lausanne

Lausanne, , Switzerland

Countries

Switzerland

Other Identifiers

ELAN

Identifier Type: -

Identifier Source: org_study_id