Clinical trial NCT06020586: Study To Evaluate The Efficacy And Safety Profile of ECOHAIR in Chemo-induced Alopecia.
Official title: Phase 2 Study to Evaluate the Efficacy and Safety of ECOHAIR Hair Lotion in the Accelerated Recovery of Chemotherapy-induced Alopecia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapy-induced Alopecia
Lead sponsor: Instituto de Oncología Ángel H. Roffo
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Percentage of scalp surface area covered at 30 days.
timeFrame: 30 days
measure: Time to event, defined as the time from the start of treatment to achieve 100% total hair coverage of the scalp.
timeFrame: baseline-30 days
Secondary outcomes:
measure: Scalp hair density at 30 days.
timeFrame: 30 days
measure: Subject satisfaction questionnare.
timeFrame: baseline-30 days
measure: Incidence and severity of local skin reactions. severity according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0)
timeFrame: baseline- 60 days
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Instituto Roffo
state: Buenos Aires
Study officials:
References: