Study To Evaluate The Efficacy And Safety Profile of ECOHAIR in Chemo-induced Alopecia.

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

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

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
    Argentina

    Active - Recruiting

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