EValuation of the Impact of a TOpical Lotion on Permanent Chemotherapy Induced Hair Disorders in … (NCT02605629) | Clinical Trial Compass
CompletedNot Applicable
EValuation of the Impact of a TOpical Lotion on Permanent Chemotherapy Induced Hair Disorders in Cancer Survivors
South Korea32 participantsStarted 2016-07-13
Plain-language summary
This study aims to evaluate the Impact of a topical Lotion, CG428, on permanent chemotherapy induced hair and scalp disorders in Cancer survivors. This is a double-blind, single center, randomized, controlled trial in breast cancer survivors.
Hair condition and parameters of 61 breast cancer survivors who were previously included in DERMA study (a prospective cohort study to assess appearance changes due to breast cancer treatment completed in July, 13th,2013) will be assessed.
1. Patients whose hair parameters are below the baseline as measured before the start of the chemotherapy or
2. who complain from incomplete hair regrowth will be eligible to participate in the randomized controlled trial.
Patients who agree to participant in the study will be randomly assigned to two parallel arms (Arm 1: CG428/ Arm 2: Placebo). Patients will self-administer the study product or placebo twice per day (morning, evening) for 6 months, for the efficacy assessment.
Primary endpoint was recovery of hair thickness 6 months after intervention as assessed using Folliscope 4.0.
Secondary endpoints included hair density at 6 months after intervention, distress due to chemotherapy induced alopecia, scalp skin parameters (water and sebum). Patient-reported hair quality improvement, body image and quality of life, and time to first visible improvement based on global photographs of hair and nails.
Who can participate
Age range
19 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* hair parameters obtained before the start of chemotherapy
* hair parameters obtained 6 months after the completion of chemotherapy
* whose hair parameters are below the baseline, as measured before the start of chemotherapy during DERMA study, or
* who complain from incomplete hair regrowth at the time of enrollment (on average 24 months after chemotherapy completion)
* Able to keep their hair style
* Able to use the study treatment in compliance with the protocol.
* Physical (ECOG≤1) and psychological ability to participate
Exclusion Criteria:
* Concomitant use of other anti-hair-loss treatment or hair growth treatment.
* Patients with recent hair transplants or who plan to have transplants.
* Known allergy or hypersensitivity to some components of CG428 (including allium cepa (onion), citrus, caffeine, the obromine)
* Pre-existing alopecia or significant scalp disease, which may alter study treatment administration or absorption.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recovery rate of hair thickness 6 months after intervention Using Folliscope 4.0, LeadM