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

Alopecia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02919735
• Other study ID #: ELAN
• Status: Completed
• Phase: Phase 2
• Start date: October 2016
• Est. completion date: March 1, 2019

Study information

• Verified date: August 2019
• Source: Legacy Healthcare SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase II clinical trial

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

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 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

Locations

Country	Name	City	State
Switzerland	CHUV Lausanne	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Legacy Healthcare SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	Patient's subjective assessment through questionnaire		Every 3 weeks for 24 weeks.