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

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 hypothyroidism, hyperthyroidism or pheochromocytoma;
• •Signs or symptoms of cardiopathy or angina;
• •History of edema from any etiology;
• •Participants who are using tricycle antidepressants, benzodiazepines, antipsychotics, anticholinergics, sulfonamide derivatives, beta-blockers, sympathomimetics, arginine, glucocorticoid or monoamine oxidase inhibitors;
• •Use of inhibitor of 5-alpha reductase or androgenic blockers in the last 12 months;
• •Dermatologic diseases of the scalp, except mild seborrheic dermatitis or diagnosis of any kind of alopecia other than female pattern hair loss;
• •History of surgical treatment for hair loss or presence of shaved scalp;
• •Scalp microinfusion, microneedling or intradermotherapy in the last 3 years;
• •Vaginal or cesarean deliveries 6 months before the inclusion in the study;
• •Drastic modification of habitual diet, as food restrictions or hyperselectivity;
• •Current cancer or history of cancer in the last 5 years;
• •Participation in others research protocols in the last 12 months, unless the investigator judges that there may be a direct benefit to the participant.