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

DesconocidoClinicalTrials.gov

ID: NCT06020586Tipo: INTERVENTIONALInicio: 6 de jun de 2022Fin estimado: 30 de dic de 2023

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: FEMALE

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

other

hair lotion

ECOHAIR

Ubicaciones

Instituto Roffo

Caba, Buenos Aires, Argentina

Maria F Guerra · mariaflorenciaguerra87@gmail.com · 011 5287-5219

RECRUITING

Patrocinadores

PrincipalInstituto de Oncología Ángel H. Roffo

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