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NCT05824065 | NOT YET RECRUITING | Female Pattern Baldness

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

EMS

Brief 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.

Condition or disease

Female Pattern Baldness

Intervention/treatment

OMA102

OMA102

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 504 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-01
Estimated Primary Completion Date : 2027-01
Estimated Study Completion Date : 2027-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 50 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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.
Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss

Location Details

NCT05824065

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Brazil, São Paulo

EMS

Hortolândia, São Paulo, Brazil,