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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMA102 1 mg | Experimental | Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep |
|
| OMA102 2 mg | Experimental | Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep |
|
| Placebo | Placebo Comparator | Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMA102 | Drug | 1 mg |
| |
| OMA102 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cassiano Ricardo O Berto, B.S. | Contact | +551938877724 | pesquisa.clinica@ncfarma.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EMS | Hortolândia | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Drug |
2 mg |
|
| Placebo | Drug | OMA102 - Placebo |
|
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. |
| 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. | 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. | 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. | 3 and 6 months |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |