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

Primary Purpose

Alopecia

Status

Completed

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

CG 428 cutaneous solution

Placebo cutaneous solution

About this trial

This is an interventional supportive care trial for Alopecia focused on measuring Alopecia, Hair, Chemotherapy, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

CHUV Lausanne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CG 428 cutaneous solution

Placebo cutaneous solution

Arm Description

Herbal Medicinal Product, topical use by spray on the scalp

Placebo, topical use by spray on the scalp

Outcomes

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)

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.

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. .

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

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.

Olsen's visual analog scale : visual aid for estimating percentage scalp hair loss.

Adverse events based on the CTCAE 4.03.

Patient's subjective assessment through questionnaire

Full Information

NCT ID

NCT02919735

First Posted

September 18, 2016

Last Updated

August 12, 2019

Sponsor

Legacy Healthcare SA

1. Study Identification

Unique Protocol Identification Number

NCT02919735

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

October 2016 (Actual)

Primary Completion Date

July 2018 (Actual)

Study Completion Date

March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Legacy Healthcare SA

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alopecia

Keywords

Alopecia, Hair, Chemotherapy, Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CG 428 cutaneous solution

Arm Type

Experimental

Arm Description

Herbal Medicinal Product, topical use by spray on the scalp

Arm Title

Placebo cutaneous solution

Arm Type

Placebo Comparator

Arm Description

Placebo, topical use by spray on the scalp

Intervention Type

Drug

Intervention Name(s)

CG 428 cutaneous solution

Intervention Description

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

Intervention Name(s)

Placebo cutaneous solution

Intervention Description

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

Primary Outcome Measure Information:

Title

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)

Description

Physical examination of the scalp: skin AEs, hair status (alopecia graded according to CTCAE v.4.03.)

Time Frame

Every 3 to 8 weeks (variable). The following investigations will be performed every 3 to 4 weeks during the study treatment

Secondary Outcome Measure Information:

Title

Rate of grade 2 alopecia according to CTCAE v. 4.03.

Description

CTCAE v. 4.03 : Common Toxicity Criteria for Adverse Event (skin toxicity)

Time Frame

Every 3 weeks for 24 weeks.

Title

Time to reach grade 2 alopecia during chemotherapyaccording to CTCAE v. 4.03. .

Description

CTCAE v. 4.03 : Common Toxicity Criteria for Adverse Event (skin toxicity)

Time Frame

Every 3 weeks for 24 weeks.

Title

Time to recover to grade 1 and grade 0 according to CTCAE v. 4.03 after the last dose of the selected chemotherapy

Description

CTCAE v. 4.03 : Common Toxicity Criteria for Adverse Event (skin toxicity)

Time Frame

Every 3 weeks for 24 weeks.

Title

Percent of hair loss according to OVAS (Olsen's visual analog scale) at different time points after the end of the chemotherapy.

Description

Olsen's visual analog scale : visual aid for estimating percentage scalp hair loss.

Time Frame

Every 3 to 8 weeks (variable). The following investigations will be performed every 3 to 4 weeks during the study treatment

Title

Adverse events based on the CTCAE 4.03.

Time Frame

Every 3 to 8 weeks (variable). The following investigations will be performed every 3 to 4 weeks during the study treatment

Title

Patient's subjective assessment through questionnaire

Time Frame

Every 3 weeks for 24 weeks.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Khalil KZ ZAMAN

Organizational Affiliation

Department Oncology - CHUV, 1011 Lausanne - CH

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHUV Lausanne

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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