To Evaluate the Efficacy and Safety of Shampoo TD03 and TD07 in Scalp Diseases (TD0307)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Scalp Dermatitis
• Intervention / Treatment: Other: TD03; Other: TD07; Drug: Ketoconazole 2% Shampoo

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 Type: Interventional
• Enrollment (Anticipated): 366
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Van Nguyen Thi Hong, MSC; Phone Number: (+84) 916451269; Email: vannh@thaiduong.com.vn

Study Locations

• Vietnam
  • Hanoi, Vietnam, 100000
    • Recruiting
    • Nationa Hospital of Dermatology
    • Contact: Phuong Pham Thi Minh; Phone Number: 04.3852.1179

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sao Thai Duong Joint Stock Company
• Collaborators: Big Leap Clinical Research Support Joint Stock Company
• Investigators: Principal Investigator: Phuong TM Pham, National Hospital of Dermatology

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: February 16, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Ketoconazole
• Other Study ID Numbers: TD0307.03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No