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

Phase 2 Study to Evaluate the Efficacy and Safety of ECOHAIR Hair Lotion in the Accelerated Recovery of Chemotherapy-induced Alopecia.

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.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy-induced Alopecia
• Intervention / Treatment: Other: hair lotion

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, 1417
      • Recruiting
      • Instituto Roffo
      • Contact: Maria F Guerra; Phone Number: 011 5287-5219; Email: mariaflorenciaguerra87@gmail.com
      • Contact: Email: mariaflorenciaguerra87@gmail.com
      • Principal Investigator: Florencia Guerra, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hair lotion	Other: hair lotion; ECOHAIR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scalp hair density at 30 days.		30 days
Subject satisfaction questionnare.	questionnaire is related to satisfaction with the outcome of the treatment (lotion).	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

Collaborators and Investigators

• Sponsor: Instituto de Oncología Ángel H. Roffo

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Estimated): August 31, 2023

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: roffo

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No