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| Name | Class |
|---|---|
| Big Leap Research | OTHER |
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Scalp Conditions are common chronic skin inflamations with the occurence rate of 1 - 5 % among the population. TD03 shampoo and TD07 shampoo are widely used to avoid hair loss with successful rate reaching nearly 95%. This trial is going to evaluate the efficacy of getting rid of dandruff as well as the safety of the investigational products in comparison to a reference (ketoconazole 2%) during a 4-week treatment period.
Scalp Conditions are common chronic skin inflamations with the occurence rate of 1 - 5 % among the population. TD03 shampoo and TD07 shampoo are widely used to avoid hair loss with successful rate reaching nearly 95%. With herbal ingredients including Gleditsia, Morus alba, Ocimum tenuiflorum, Oroxylum indicum, Ageratum conyzoides, the investigational products could reduce the severity of inflamation, infection and help to prevent hair loss. This trial is planning to evaluate the efficacy of the IPs in terms of inflamation reduction, dandruff reduction on subjects using the IPs compared to a reference (ketoconazole 2%).
The trial is intended to last for 18 months with subject visits and 3 arms (122 subjects per arm). The first arm receive TD3 while TD7 is provided to the second arm in comparison to the placebo of the last arm. It will be conducted at National Hospital of Dermato - Venerology, Vietnam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD3 | Experimental | TD3, bi-daily x 4 weeks |
|
| TD7 | Experimental | TD7, bi-daily x 4 weeks |
|
| Ketoconazole 2% | Active Comparator | Ketoconazole 2% shampoo bi-daily x 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD03 | Other | Shampoo TD 3 days |
| |
| TD07 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in IGA scale at 4 week-treatment | Change from baseline in IGA scale at 4 week-treatment of TD3 and TD7 compared to that of Ketoconazole 2% shampoo. | 4 weeks |
| The numbers of subjects with AE/SAE | The numbers of subjects with AE/SAE as defined in the protocol. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Van Nguyen Thi Hong, MSC | Contact | (+84) 916451269 | vannh@thaiduong.com.vn |
| Name | Affiliation | Role |
|---|---|---|
| Phuong TM Pham | National Hospital of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationa Hospital of Dermatology | Recruiting | Hanoi | 100000 | Vietnam |
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| ID | Term |
|---|---|
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Other |
Shampoo TD 7 days |
|
| Ketoconazole 2% Shampoo | Drug | Ketoconazole 2% Shampoo |
|