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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
ECOHAIR
Instituto Roffo
Caba, Buenos Aires, Argentina
RECRUITINGPercentage 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 frame: 30 days
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
Scalp hair density at 30 days.
Time frame: 30 days
Subject satisfaction questionnare.
questionnaire is related to satisfaction with the outcome of the treatment (lotion).
Time frame: 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)
Time frame: baseline- 60 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.