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

Phase 3

• Conditions: Scalp Dermatitis
• Interventions: Other: TD03; Other: TD07; Drug: Ketoconazole 2% Shampoo

• Registration Number: NCT03845348
• Lead Sponsor: Sao Thai Duong Joint Stock Company

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.

Study Timeline

• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-02-16
• Study First Posted: 2019-02-19
• Study Start: 2019-05-22
• Status Verified: 2022-06
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26
• Primary Completion: 2022-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 366

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TD3	TD03	TD3, bi-daily x 4 weeks
TD7	TD07	TD7, bi-daily x 4 weeks
Ketoconazole 2%	Ketoconazole 2% Shampoo	Ketoconazole 2% shampoo bi-daily x 4 weeks

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nationa Hospital of Dermatology; 🇻🇳 Hanoi, Vietnam