Study To Evaluate The Efficacy And Safety Profile of ECOH... | NCT06020586

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

NCT06020586

Sponsor

Instituto de Oncología Ángel H. Roffo

Status

Unknown status

Last Update Posted

Aug 31, 2023Actual

Enrollment

22Estimated

Phase

Not Applicable

Conditions

Chemotherapy-induced Alopecia

Interventions

hair lotion

Countries

Argentina

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2022Actual

Primary Completion Date

Nov 1, 2023Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Jun 1, 2023

First Submission Date that Met QC Criteria

Aug 29, 2023

First Posted Date

Aug 31, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2023

Last Update Posted Date

Aug 31, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Estimated

Label	Type	Description	Intervention Names
hair lotion	Experimental		Other: hair lotion

Name	Type	Description	Arm Group Labels	Other Names
hair lotion	Other	ECOHAIR	hair lotion

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided