search
Back to results

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

Primary Purpose

Chemotherapy-induced Alopecia

Status
Recruiting
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
hair lotion
Sponsored by
Instituto de Oncología Ángel H. Roffo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-induced Alopecia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto RoffoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hair lotion

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 1, 2023
Last Updated
August 29, 2023
Sponsor
Instituto de Oncología Ángel H. Roffo
search

1. Study Identification

Unique Protocol Identification Number
NCT06020586
Brief Title
Study To Evaluate The Efficacy And Safety Profile of ECOHAIR in Chemo-induced Alopecia.
Official Title
Phase 2 Study to Evaluate the Efficacy and Safety of ECOHAIR Hair Lotion in the Accelerated Recovery of Chemotherapy-induced Alopecia.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Oncología Ángel H. Roffo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hair lotion
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
hair lotion
Intervention Description
ECOHAIR
Primary Outcome Measure Information:
Title
Percentage of scalp surface area covered at 30 days.
Description
The primary efficacy assessment is hair count in the target area (in a 1 cm2 circular area) using trichoscopy imaging.
Time Frame
30 days
Title
Time to event, defined as the time from the start of treatment to achieve 100% total hair coverage of the scalp.
Time Frame
baseline-30 days
Secondary Outcome Measure Information:
Title
Scalp hair density at 30 days.
Time Frame
30 days
Title
Subject satisfaction questionnare.
Description
questionnaire is related to satisfaction with the outcome of the treatment (lotion).
Time Frame
baseline-30 days
Title
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)
Time Frame
baseline- 60 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Instituto Roffo
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1417
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria F Guerra
Phone
011 5287-5219
Email
mariaflorenciaguerra87@gmail.com
Ext
Guerra
Email
mariaflorenciaguerra87@gmail.com
First Name & Middle Initial & Last Name & Degree
Florencia Guerra, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs