Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss
- Registration Number
- NCT05824065
- Lead 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 504
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep OMA102 2 mg OMA102 Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep OMA102 1 mg OMA102 Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep
- Primary Outcome Measures
Name Time Method Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram. 6 months Variation of hair in the mid-front area after 6 months of treatment in comparison to baseline, assessed by digital phototrichogram.
- Secondary Outcome Measures
Name Time Method Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram. 3 months Variation of hair in the mid-front area after 3 months of treatment in comparison to baseline, assessed by digital phototrichogram.
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. 3 and 6 months 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.
Efficacy of OMA102 1 mg and OMA102 2 mg in quality of life, assessed by Women's Androgenetic Alopecia Quality of Life (WAA-QoL). 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) in comparison to baseline, 3 and 6 months after treatment.
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. 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 investigator perception, 3 and 6 months after treatment.
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. 3 and 6 months 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.
Trial Locations
- Locations (1)
EMS
🇧🇷Hortolândia, São Paulo, Brazil