Study To Evaluate The Efficacy And Safety Profile of ECOHAIR in Chemo-induced Alopecia. (NCT06020586) | Clinical Trial Compass
UnknownNot Applicable
Study To Evaluate The Efficacy And Safety Profile of ECOHAIR in Chemo-induced Alopecia.
Argentina22 participantsStarted 2022-06-06
Plain-language summary
This is a Phase 2, single-center study designed to determine the effect of ECOHAIR topical solution on scalp hair growth evaluated objectively ( images) and subjectively ( patient and investigator reports). A total of 22 subjects are planned to be enrolled, 15 in a prospective single-arm phase in which they will receive the study treatment and 7 controls. Patients should have a clinical diagnosis of chemotherapy-induced alopecia.
Who can participate
Age range
18 Years – 65 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:
* Women diagnosed with stage I to III breast/ovarian cancer aged 18 to 65 years.
* Receiving chemotherapeutic agents containing taxanes and/or anthracyclines.
* Willing to agree to shave thinning hair at baseline.
* Willingness to be photographed and consent to photographic disclosure.
* Able to understand and willing to sign an informed consent form.
* Willing and able to follow all study instructions and attend all study visits.
* Subjects taking thyroid replacement medication must be on stable doses for 6 months prior to enrollment and remain on the same maintenance dose throughout the study.
* If female of childbearing age, must have a negative serum or urine pregnancy test at screnning (visit 0). Use a highly effective method of contraception during the study; do not plan a pregnancy for the duration of the study.
Exclusion Criteria:
* Use of any products or devices used to promote scalp hair growth (e.g., finasteride or minoxidil, L-tyrosine, cold caps).
* Sensitivity or allergy to any ingredient in the Ecohair product.
* Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or history of skin disease on the scalp that, in the opinion of the investigator, may interfere with the efficacy or safety evaluations of the study.
* Active scalp trauma or other condition affecting the scalp that, in the opinion of the investigator may interfere with the conduct of the study or evaluations.
* The presence of a permanent or difficult …
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
Percentage of scalp surface area covered at 30 days.
Timeframe: 30 days
2
Time to event, defined as the time from the start of treatment to achieve 100% total hair coverage of the scalp.