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

Study Overview
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Brief Summary
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Phase II clinical trial

Detailed Description
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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.

Official Title
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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

Conditions
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Alopecia

Intervention / Treatment
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* Drug: CG 428 cutaneous solution
* Drug: Placebo cutaneous solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CG 428 cutaneous solution<br>Herbal Medicinal Product, topical use by spray on the scalp | Drug: CG 428 cutaneous solution<br>* 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<br>|
| Placebo Comparator: Placebo cutaneous solution<br>Placebo, topical use by spray on the scalp | Drug: Placebo cutaneous solution<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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 | 
| 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 | 
| Patient's subjective assessment through questionnaire |  | Every 3 weeks for 24 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Alopecia, Hair, Chemotherapy