Alopecia
Conditions
Keywords
Alopecia, Hair, Chemotherapy, Cancer
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.
Interventions
DRUGCG 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
DRUGPlacebo 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
Sponsors
Legacy Healthcare SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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. | — |
| 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. |
Countries
Switzerland
Outcome results
None listed