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

NCT06020586 | Unknown

• 1 other identifier: roffo
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Percentage of scalp surface area covered at 30 days.

  The primary efficacy assessment is hair count in the target area (in a 1 cm2 circular area) using trichoscopy imaging.

  30 days

• Time to event, defined as the time from the start of treatment to achieve 100% total hair coverage of the scalp.

  baseline-30 days

Secondary Outcomes (3)

• Scalp hair density at 30 days.

  30 days

• Subject satisfaction questionnare.

  baseline-30 days

• Incidence and severity of local skin reactions. severity according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0)

  baseline- 60 days

Study Arms (1)

hair lotion

EXPERIMENTAL

Other: hair lotion

Interventions

hair lotion OTHER

ECOHAIR

hair lotion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Oncología Ángel H. Roffo: lead

Study Sites (1)

Instituto Roffo

Caba, Buenos Aires, 1417, Argentina

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: August 31, 2023
• Study Start: June 6, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 30, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

AR (1)