Phase III, National, Multicenter, Randomized, Double-Blind, Superiority Clinical Trial to Evaluate the Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss

EMS1 site in 1 country504 target enrollmentJanuary 2025

ConditionsFemale Pattern Baldness

InterventionsPlacebo OMA102

DrugsOMA102 Placebo

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Female Pattern Baldness
Sponsor: EMS
Enrollment: 504
Locations: 1
Primary Endpoint: Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram.
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to evaluate the efficacy and safety of OMA102 1 mg and OMA102 2 mg versus placebo in the treatment of female pattern hair loss.

Registry

clinicaltrials.gov

Start Date

January 2025

End Date

January 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

EMS

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
•Age greater than 18 and equal or under 50 years;
•Confirmed diagnosis of female pattern hair loss, grade II to IV in Sinclair Scale;
•Participants that are disposed to maintain the same hair color, style, approximate hair length throughout the Clinical Study.

Exclusion Criteria

•Any clinical or physical finding interpreted by the investigator as a risk to subject participation in the Clinical Study
•History of alcohol or illicit drugs abuse in the last year;
•Pregnant or breastfeeding women, who are planning to become pregnant or participants who have childbearing potential and are not using any reliable contraceptive method;
•Allergy or sensibility to any knowing components of the formula;
•Diagnosis of arterial hypertension;
•History of vasovagal syncope;
•Baseline systolic blood pressure lower than 90 mmHg and/or diastolic lower than 60 mmHg;
•Diagnosis of orthostatic hypotension (reduction of systolic blood pressure equal or superior to 20 mmHg and/or diastolic equal or superior to 10 mmHg after 3 minutes in orthostatic position);
•Body mass index (BMI) \> 30 kg/m²;
•Subjects that initiated any kind of continue use medication, including contraceptives with systemic effect, until 3 months previously the inclusion in the Clinical Study;

Arms & Interventions

Placebo

Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep

Intervention: Placebo

OMA102 1 mg

Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep

Intervention: OMA102

OMA102 2 mg

Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep

Intervention: OMA102

Outcomes

Primary Outcomes

Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram.

Time Frame: 6 months

Variation of hair in the mid-front area after 6 months of treatment in comparison to baseline, assessed by digital phototrichogram.

Secondary Outcomes

Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram.(3 months)
Efficacy of OMA102 1 mg and OMA102 2 mg in the proportion of subjects with an improvement of global photographs, assessed by Clinical Global Impression of Improvement (CGI-I) by the investigator perception.(3 and 6 months)
Efficacy of OMA102 1 mg and OMA102 2 mg in quality of life, assessed by Women's Androgenetic Alopecia Quality of Life (WAA-QoL).(3 and 6 months)
Efficacy of OMA102 1 mg and OMA102 2 mg in the proportion of subjects with an improvement of global photographs, assessed by Patient Global Impression, PGI-I, by the subject perception.(3 and 6 months)
Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of non vellus and vellus hair growth, in the mid frontal area, assessed by digital phototrichogram.(3 and 6 months)