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)
1 other identifier
interventional
366
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2019
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2019
CompletedFirst Posted
Study publicly available on registry
February 19, 2019
CompletedStudy Start
First participant enrolled
May 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedOctober 26, 2022
June 1, 2022
3.5 years
January 10, 2019
October 25, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
TD3
EXPERIMENTALTD3, bi-daily x 4 weeks
TD7
EXPERIMENTALTD7, bi-daily x 4 weeks
Ketoconazole 2%
ACTIVE COMPARATORKetoconazole 2% shampoo bi-daily x 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- \> 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sao Thai Duong Joint Stock Companylead
- Big Leap Researchcollaborator
Study Sites (1)
Nationa Hospital of Dermatology
Hanoi, 100000, Vietnam
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Phuong TM Pham
National Hospital of Dermatology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2019
First Posted
February 19, 2019
Study Start
May 22, 2019
Primary Completion
December 1, 2022
Study Completion
June 1, 2023
Last Updated
October 26, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share