To Evaluate the Efficacy and Safety of Shampoo TD03 and TD07 in Scalp Diseases

Study Overview
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Brief Summary
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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.

Detailed Description
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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%. 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.

Official Title
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Đánh giá hiệu quả điều trị viêm da dầu ở đầu của dầu gội Thái Dương 3 và Thái Dương 7 (A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy Shampoos TD03 and TD07 in Scalp Diseases)

Conditions
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Scalp Dermatitis

Intervention / Treatment
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* Other: TD03
* Other: TD07
* Drug: Ketoconazole 2% Shampoo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years old and signed the ICF. Diagnosed with head skin inflamtion with IGA <= 3. Voluntary sign the ICF before any procedures. No hypersentivity to the IP. Exclusion Criteria: Use oral antifungal 1 month prior to the trial participation or topical antifungal 2 weeks prior to the trial participation. Suffering chronic or acute diseases that may affect the trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD3<br>TD3, bi-daily x 4 weeks | Other: TD03<br>* Shampoo TD 3 days<br>|
| Experimental: TD7<br>TD7, bi-daily x 4 weeks | Other: TD07<br>* Shampoo TD 7 days<br>|
| Active Comparator: Ketoconazole 2%<br>Ketoconazole 2% shampoo bi-daily x 4 weeks | Drug: Ketoconazole 2% Shampoo<br>* Ketoconazole 2% Shampoo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |