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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2008-001770-33 |
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The purpose of this study is to determine in women the risk/benefit profile and non-inferiority of a topical 5% Minoxidil foam formulation applied once daily for the treatment of androgenetic alopecia in comparison to 2% MTS used twice daily, using objective and subjective efficacy measures and safety assessments for a study period of 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5% MTF | Active Comparator | 5% minoxidil topical foam used once daily |
|
| 2% MTS | Active Comparator | 2% minoxidil topical solution twice daily use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| minoxidil | Drug | the investigators compared two different formulations and concentrations of minoxidil in this study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of target area non-vellus hair count (TAHC) [n/cm²] after 24 weeks | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing the investigational products safety by means of clinical examination (local intolerance, facial hypertrichosis, AE, SAE) and blood Minoxidil level (baseline + week 24) | 24 weeks | |
| Change of cumulative hair width in non-vellus hair (TAHW) after 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité-Universitaetsmedizin; Clinical Research Center for Hair and Skin Science | Berlin | 10117 | Germany |
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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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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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| 24 weeks |
| Global expert panel rating of change in scalp coverage via assessment of global photographs | 24 weeks |
| Volunteer questionnaire rating for administration and contentment of the study product | 24 weeks |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |