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

Phase 2

Completed

• Conditions: Alopecia
• Interventions: Drug: CG 428 cutaneous solution; Drug: Placebo cutaneous solution

• Registration Number: NCT02919735
• Lead Sponsor: Legacy Healthcare SA

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.

Study Timeline

• Study First Submitted: 2016-09-18
• Study First Submitted QC: 2016-09-28
• Study First Posted: 2016-09-29
• Study Start: 2016-10
• Primary Completion: 2018-07
• Study Completion: 2019-03-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CG 428 cutaneous solution	CG 428 cutaneous solution	Herbal Medicinal Product, topical use by spray on the scalp
Placebo cutaneous solution	Placebo cutaneous solution	Placebo, topical use by spray on the scalp

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
Patient's subjective assessment through questionnaire	Every 3 weeks for 24 weeks.
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

Trial Locations

Locations (1)

CHUV Lausanne; 🇨🇭 Lausanne, Switzerland