Status:
UNKNOWN
Study To Evaluate The Efficacy And Safety Profile of ECOHAIR in Chemo-induced Alopecia.
Lead Sponsor:
Instituto de Oncología Ángel H. Roffo
Conditions:
Chemotherapy-induced Alopecia
Eligibility:
FEMALE
18-65 years
Phase:
NA
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 rep...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06020586
Start Date
June 6 2022
End Date
December 30 2023
Last Update
August 31 2023
Active Locations (1)
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1
Instituto Roffo
Caba, Buenos Aires, Argentina, 1417