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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат OMA102
  1 mg
• Препарат OMA102
  2 mg
• Препарат Placebo
  OMA102 - Placebo

Первичные конечные точки

• Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram. [Срок оценки: 6 months]

Вторичные конечные точки (5)

• Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: 3 and 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• EMS — Hortolândia

Идентификаторы

NCT: NCT05824065 · OMA102-III-0123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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