Clinical trial NCT05824065: Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Female Pattern Baldness
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2023-04-21
Enrollment: 504
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram.
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram.
timeFrame: 3 months
measure: 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.
timeFrame: 3 and 6 months
measure: 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.
timeFrame: 3 and 6 months
measure: 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.
timeFrame: 3 and 6 months
measure: Efficacy of OMA102 1 mg and OMA102 2 mg in quality of life, assessed by Women's Androgenetic Alopecia Quality of Life (WAA-QoL).
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Hortolândia
country: Brazil
facility: EMS
state: São Paulo
Study officials:
References: