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

Scalp Dermatitis Clinical Trial

— TD0307  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03845348
• Other study ID #: TD0307.03
• Status: Recruiting
• Phase: Phase 3
• Start date: May 22, 2019
• Est. completion date: June 2023

Study information

• Verified date: June 2022
• Source: Sao Thai Duong Joint Stock Company
• Contact: Van Nguyen Thi Hong, MSC
• Phone: (+84) 916451269
• Email: vannh[@]thaiduong.com.vn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 366
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Scalp Dermatitis

Intervention

Other:
• TD03
Shampoo TD 3 days
• TD07
Shampoo TD 7 days

Drug:
• Ketoconazole 2% Shampoo
Ketoconazole 2% Shampoo

Locations

Country	Name	City	State
Vietnam	Nationa Hospital of Dermatology	Hanoi

Sponsors (2)

Lead Sponsor	Collaborator
Sao Thai Duong Joint Stock Company	Big Leap Clinical Research Support Joint Stock Company

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The numbers of subjects with AE/SAE	The numbers of subjects with AE/SAE as defined in the protocol.	4 weeks