Female Pattern Baldness
Conditions
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.
Interventions
DRUGOMA102
1 mg
DRUGPlacebo
OMA102 - Placebo
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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 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. |
Countries
Brazil
Contacts
Primary ContactCassiano Ricardo O Berto, B.S.
Outcome results
None listed