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| Name | Class |
|---|---|
| A2 Healthcare Taiwan Corporation | INDUSTRY |
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The objective of this study is to evaluate the efficacy and safety of ENERGI-F701 Solution in female subjects with hair loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENERGI-F701 | Experimental | ENERGI-F701, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks |
|
| Regaine | Active Comparator | Regaine, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENERGI-F701 | Drug | ENERGI-F701 are applied for treatment of hair loss. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of hair loss | Change of the amount of hair loss at Week 12 from baseline.(hair loss is defined as the collection of hairs after combing at the study site) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of hair loss at each post-treatment visit | Week 2, 4, 6, 8, 10 | |
| The thickness and density of hair | Change of hair thickness and density measured by phototrichogram at each post-treatment visit |
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Inclusion Criteria:
Exclusion Criteria:
Any subject meeting any of the exclusion criteria will be excluded from study participation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | Taiwan |
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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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| Regaine |
| Drug |
Regaine are applied for treatment of hair loss. |
|
| Week 2, 4, 6, 8, 10, 12 |
| Investigator assessment at each post-treatment visit | The hair loss will be assessed by the investigator using Investigator Photographic Assessment Questionnaire (IPAQ).The change from Baseline in hair growth will be assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. | Week 2, 4, 6, 8, 10, 12 |
| The hair wash/shed hair count at each post-treatment visit | Subjects will collect hairs full day, including after combing and hair-washing. Subjects should turn in these hair collections at each visit. The results will be averaged weekly. | Week 2, 4, 6, 8, 10, 12 |
| The subject satisfaction | Subject satisfaction evaluated by Women's Androgenic Alopecia Quality of Life Questionnaire (WAA-QOL) at each post-treatment visit from baseline. WAA-QOL is a sixteen-question questionnaire to evaluate subjects' quality of life influenced by hair loss. Each question will be assessed using the following 7-point scale: 0 = not at all, 1 = a little bit, 2 = somewhat, 3 = a good bit, 4 = quite a bit , 5 = very much, 6 = extremely. | Week 2, 4, 6, 8, 10, 12 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |