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

EMS

Status and phase: Not yet enrolling; Phase 3

Conditions: Female Pattern Baldness

Treatments: Drug: OMA102; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05824065

OMA102-III-0123

Details and patient eligibility

About

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.

Enrollment: 504 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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;
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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504 participants in 3 patient groups, including a placebo group

OMA102 1 mg

Experimental group

Description:

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

Treatment:

Drug: OMA102

Drug: OMA102

OMA102 2 mg

Experimental group

Description:

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

Treatment:

Drug: OMA102

Drug: OMA102

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo