Evaluating ECOHAIR for hair growth in chemotherapy patients

Phase 2 Study to Evaluate the Efficacy and Safety of ECOHAIR Hair Lotion in the Accelerated Recovery of Chemotherapy-induced Alopecia.

This study is testing a new hair growth solution called ECOHAIR to see if it helps women with breast or ovarian cancer who are losing their hair from chemotherapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: Instituto de Oncología Ángel H. Roffo (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Caba, Buenos Aires)
• Trial ID: NCT06020586 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of ECOHAIR, a topical solution, in promoting hair growth for women experiencing chemotherapy-induced alopecia. It will involve 22 participants, with 15 receiving the treatment and 7 serving as controls. The evaluation will be conducted through objective imaging and subjective reports from both patients and investigators. Participants must be women aged 18 to 65 with a diagnosis of breast or ovarian cancer undergoing specific chemotherapy regimens.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 65 diagnosed with stage I to III breast or ovarian cancer who are undergoing chemotherapy with taxanes and/or anthracyclines.

Not a fit: Patients who are using other hair growth products or devices will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from hair loss due to chemotherapy.

How similar studies have performed: While there is limited information on similar studies, the approach of using topical solutions for hair regrowth in chemotherapy-induced alopecia is relatively novel.

Eligibility criteria

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 to remove hairpiece or wig that, in the opinion of the investigator, will interfere with study evaluations if not removed at each visit.
* Failure to be able to perform assigned clinical visits.

Where this trial is running

Caba, Buenos Aires

• Instituto Roffo — Caba, Buenos Aires, Argentina (RECRUITING)

Conditions: Chemotherapy-induced Alopecia