AlopeciaPhase 2ELANNCT02919735
Efficacy, Safety and Tolerability of CG428 Cutaneous Solution on Chemotherapy Induced Alopecia; Controlled Study (ELAN)
A Phase 2 study testing CG 428 cutaneous solution in people with Alopecia, run by Legacy Healthcare SA at 1 site in Switzerland.
Trial summary
Phase II clinical trial Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Alopecia
- What is being tested?
- CG 428 cutaneous solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2016to 1 Mar 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Phase II clinical trial
Read the 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.
- Conditions
- Alopecia
- Being tested
- CG 428 cutaneous solution, Placebo cutaneous solution
- Keywords
- Alopecia, Hair, Chemotherapy, Cancer
- Medical subject headings
- Alopecia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG 428 cutaneous solutionDrug
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 solutionDrug
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
| Study group | Role | What they receive |
|---|---|---|
| CG 428 cutaneous solution | Experimental | Herbal Medicinal Product, topical use by spray on the scalp Receives: Drug: CG 428 cutaneous solution |
| Placebo cutaneous solution | Placebo comparator | Placebo, topical use by spray on the scalp Receives: Drug: Placebo cutaneous solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.
CTCAE v. 4.03 : Common Toxicity Criteria for Adverse Event (skin toxicity)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: Every 3 weeks for 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Legacy Healthcare SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Khalil KZ ZAMAN, Principal investigator, Department Oncology - CHUV, 1011 Lausanne - CH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919735
- Sponsor's protocol ID
- ELAN
- Acronym
- ELAN
- Status last verified
- Aug 2019
- First submitted
- 18 Sep 2016
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02919735
- Acronym / sponsor ID
- ELAN / ELAN
- Conditions
- Alopecia
- Keywords
- Alopecia, Hair, Chemotherapy, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Legacy Healthcare SAIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CG 428 cutaneous solution | Experimental | Drug: CG 428 cutaneous solutionHerbal Medicinal Product, topical use by spray on the scalp |
| Placebo cutaneous solution | Placebo comparator | Drug: Placebo cutaneous solutionPlacebo, topical use by spray on the scalp |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CG 428 cutaneous solutionThe 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 | Drug | CG 428 cutaneous solution |
| Placebo cutaneous solutionThe 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 | Drug | Placebo cutaneous solution |
Primary outcome
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)
Time frame: 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.)
6 secondary outcomes
Rate of grade 2 alopecia according to CTCAE v. 4.03.
Time frame: Every 3 weeks for 24 weeks.
Time to reach grade 2 alopecia during chemotherapyaccording to CTCAE v. 4.03. .
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Every 3 weeks for 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khalil KZ ZAMAN principal investigator
Department Oncology - CHUV, 1011 Lausanne - CH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CG 428 cutaneous solution in people with Alopecia, run by Legacy Healthcare SA at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Every 3 to 8 weeks (variable). The following investigations will be performed every 3 to 4 weeks during the study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.