Female Pattern BaldnessPhase 3GENERANCT05824065
Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss
A Phase 3 study testing OMA102 in people with Female Pattern Baldness, run by EMS at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Female Pattern Baldness
- What is being tested?
- OMA102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 504 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2025to Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Female Pattern Baldness
- Being tested
- OMA102, Placebo
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMA102Drug
1 mg
OMA102Drug
2 mg
PlaceboDrug
OMA102 - Placebo
| Study group | Role | What they receive |
|---|---|---|
| OMA102 1 mg | Experimental | Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep Receives: Drug: OMA102 |
| OMA102 2 mg | Experimental | Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep Receives: Drug: OMA102 |
| Placebo | Placebo comparator | Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (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.
Variation of hair in the mid-front area after 3 months of treatment in comparison to baseline, assessed by digital phototrichogram.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study startJan 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Pattern BaldnessStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824065
- Sponsor's protocol ID
- OMA102-III-0123
- Acronym
- GENERA
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05824065
- Acronym / sponsor ID
- GENERA / OMA102-III-0123
- Conditions
- Female Pattern Baldness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OMA102 1 mg | Experimental | Drug: OMA102Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep |
| OMA102 2 mg | Experimental | Drug: OMA102Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep |
| Placebo | Placebo comparator | Drug: PlaceboIngestion of 1 oral tablet, once a day, immediately before lying down to sleep |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMA1021 mg | Drug | OMA102 1 mg |
| OMA1022 mg | Drug | OMA102 2 mg |
| PlaceboOMA102 - Placebo | Drug | Placebo |
Primary outcome
Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram.
Time frame: 6 months
Variation of hair in the mid-front area after 6 months of treatment in comparison to baseline, assessed by digital phototrichogram.
5 secondary outcomes
Efficacy of OMA102 1 mg and OMA102 2 mg in the promotion of hair growth in the mid front area assessed by digital phototrichogram.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 3 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OMA102 in people with Female Pattern Baldness, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cassiano Ricardo O Berto, B.S. (+551938877724, pesquisa.clinica@ncfarma.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.