Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss (NCT05824065) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss
Brazil504 participantsStarted 2025-01
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 hypothyr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram.