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

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS

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;

• 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.