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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Female Pattern Baldness

Intervention / Treatment
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* Drug: OMA102
* Drug: OMA102
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMA102 1 mg<br>Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep | Drug: OMA102<br>* 1 mg<br>|
| Experimental: OMA102 2 mg<br>Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep | Drug: OMA102<br>* 2 mg<br>|
| Placebo Comparator: Placebo<br>Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep | Drug: Placebo<br>* OMA102 - Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram. | Variation of hair in the mid-front area after 6 months of treatment in comparison to baseline, assessed by digital phototrichogram. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram. | Variation of hair in the mid-front area after 3 months of treatment in comparison to baseline, assessed by digital phototrichogram. | 3 months | 
| Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of non vellus and vellus hair growth, in the mid frontal area, assessed by digital phototrichogram. | Variation of non vellus and vellus hair in the mid-front area after 3 and 6 months of treatment in comparison to baseline, assessed by digital phototrichogram. | 3 and 6 months | 
| Efficacy of OMA102 1 mg and OMA102 2 mg in the proportion of subjects with an improvement of global photographs, assessed by Clinical Global Impression of Improvement (CGI-I) by the investigator perception. | Efficacy of OMA102 1 mg and OMA102 2 mg in the proportion of subjects with an improvement global photographs assessed by Clinical Global Impression of Improvement (CGI-I) by the investigator perception, 3 and 6 months after treatment. | 3 and 6 months | 
| Efficacy of OMA102 1 mg and OMA102 2 mg in the proportion of subjects with an improvement of global photographs, assessed by Patient Global Impression, PGI-I, by the subject perception. | Efficacy of OMA102 1 mg and OMA102 2 mg in the proportion of subjects with an improvement of Global Photographs assessed by Patient Global Impression PGI-I, by the investigator perception, 3 and 6 months after treatment. | 3 and 6 months | 
| Efficacy of OMA102 1 mg and OMA102 2 mg in quality of life, assessed by Women's Androgenetic Alopecia Quality of Life (WAA-QoL). | Efficacy of OMA102 1 mg and OMA102 2 mg in quality of life, assessed by Women's Androgenetic Alopecia Quality of Life (WAA-QoL) in comparison to baseline, 3 and 6 months after treatment. | 3 and 6 months |