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

NCT ID: NCT06020586

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-06
• Study Completion Date: 2023-12-30

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.

Conditions

Chemotherapy-induced Alopecia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hair lotion

Group Type: EXPERIMENTAL

hair lotion

Intervention Type: OTHER

ECOHAIR

Interventions

hair lotion

ECOHAIR

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Oncología Ángel H. Roffo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Instituto Roffo

Caba, Buenos Aires, Argentina

Site Status: RECRUITING

Countries

Argentina

Facility Contacts

Maria F Guerra

Role: primary

mariaflorenciaguerra87@gmail.com

011 5287-5219

Role: backup

mariaflorenciaguerra87@gmail.com

Other Identifiers

roffo

Identifier Type: -

Identifier Source: org_study_id