Last updated: August 29, 2023
Sponsor: Instituto de Oncología Ángel H. Roffo
Overall Status: Active - Recruiting
Phase
N/A
Condition
Hair Loss
Alopecia
Treatment
hair lotion
Clinical Study ID
NCT06020586
roffo
Ages 18-65 Female
Study Summary
Eligibility Criteria
Inclusion
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 monthsprior 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 atscrenning (visit 0). Use a highly effective method of contraception during the study;do not plan a pregnancy for the duration of the study.
Exclusion
Exclusion Criteria:
- Use of any products or devices used to promote scalp hair growth (e.g., finasteride orminoxidil, 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) orhistory of skin disease on the scalp that, in the opinion of the investigator, mayinterfere with the efficacy or safety evaluations of the study.
- Active scalp trauma or other condition affecting the scalp that, in the opinion of theinvestigator may interfere with the conduct of the study or evaluations.
- The presence of a permanent or difficult to remove hairpiece or wig that, in theopinion of the investigator, will interfere with study evaluations if not removed ateach visit.
- Failure to be able to perform assigned clinical visits.
Study Design
Total Participants: 22
Treatment Group(s): 1
Primary Treatment: hair lotion
Phase:
Study Start date:
June 06, 2022
Estimated Completion Date:
December 30, 2023
Connect with a study center
Instituto Roffo
Caba, Buenos Aires 1417
ArgentinaActive - Recruiting

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