Scalp Dermatitis
Conditions
Brief summary
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
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.
Interventions
OTHERTD03
Shampoo TD 3 days
OTHERTD07
Shampoo TD 7 days
Ketoconazole 2% Shampoo
Sponsors
Big Leap Research
Sao Thai Duong Joint Stock Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in IGA scale at 4 week-treatment | 4 weeks | Change from baseline in IGA scale at 4 week-treatment of TD3 and TD7 compared to that of Ketoconazole 2% shampoo. |
| The numbers of subjects with AE/SAE | 4 weeks | The numbers of subjects with AE/SAE as defined in the protocol. |
Countries
Vietnam
Contacts
Primary ContactVan Nguyen Thi Hong, MSC
Outcome results
None listed