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Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss

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

NCT05824065•EMS

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 50 years

Sex

FEMALE

Healthy Volunteers

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;
+13 more criteria

Locations (1)

EMS

Hortolândia, São Paulo, Brazil

Key Dates

Start Date

January 1, 2025

Primary Completion Date

January 1, 2027

Completion Date

January 1, 2027

Last Updated

February 16, 2024

Enrollment

504

ESTIMATED participants

Conditions

Female Pattern Baldness

Interventions

OMA102

DRUG

OMA102

DRUG

Placebo

DRUG

Contacts

Cassiano Ricardo O Berto, B.S.

CONTACT

+551938877724 pesquisa.clinica@ncfarma.com.br

A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004512)

NCT01451125

Androgenetic AlopeciaMale Pattern Baldness+1 more

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COMPLETEDPHASE2

A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004541)

NCT01451138

Androgenetic AlopeciaMale Pattern Baldness+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004512)

A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004541)

Treatment of Androgenetic Alopecia in Females, 9 Beam

A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002012)