Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss (NCT05824065) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss
Brazil504 participantsStarted 2025-01
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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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;
* History of cardiovascular, liver and renal diseases;
* History of hypothyr…
What they're measuring
1
Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram.