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

NCT02919735 | Completed Phase 2 DMC

• 1 other identifier: ELAN
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II clinical trial

Conditions

Alopecia

Keywords

Alopecia; Hair; Chemotherapy; Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  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.

• 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.

• 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

• 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

Study Arms (2)

CG 428 cutaneous solution

EXPERIMENTAL

Herbal Medicinal Product, topical use by spray on the scalp

Drug: CG 428 cutaneous solution

Placebo cutaneous solution

PLACEBO COMPARATOR

Placebo, topical use by spray on the scalp

Drug: Placebo cutaneous solution

Interventions

CG 428 cutaneous solution 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

CG 428 cutaneous solution

Placebo cutaneous solution 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Legacy Healthcare SA: lead

Study Sites (1)

CHUV Lausanne

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Alopecia; Neoplasms

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Khalil KZ ZAMAN

  Department Oncology - CHUV, 1011 Lausanne - CH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2016
• First Posted: September 29, 2016
• Study Start: October 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: March 1, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)