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

• Sponsor: Sao Thai Duong Joint Stock Company (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03845348
• Collaborator: Big Leap Clinical Research Support Joint Stock Company (Other)
• Enrollment: 366
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 48.3
• Patients Per Site Per Month: 7.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Scalp Dermatitis	Other: TD03; Other: TD07; Drug: Ketoconazole 2% Shampoo	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 366 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: May 22, 2019
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. The numbers of subjects with AE/SAE [4 weeks]

   The numbers of subjects with AE/SAE as defined in the protocol.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationa Hospital of Dermatology	Hanoi		Vietnam	100000

Sponsors and Collaborators

• Sao Thai Duong Joint Stock Company
• Big Leap Clinical Research Support Joint Stock Company

Investigators

• Principal Investigator: Phuong TM Pham, National Hospital of Dermatology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sao Thai Duong Joint Stock Company
• ClinicalTrials.gov Identifier: NCT03845348
• Other Study ID Numbers: TD0307.03
• First Posted: Feb 19, 2019
• Last Update Posted: Sep 14, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dermatitis; Ketoconazole

Study Results

No Results Posted as of Sep 14, 2021