Scalp DermatitisPhase 3TD0307NCT03845348
To Evaluate the Efficacy and Safety of Shampoo TD03 and TD07 in Scalp Diseases
A Phase 3 study testing TD03 and TD07 in people with Scalp Dermatitis, run by Sao Thai Duong Joint Stock Company at 1 site in Vietnam.
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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scalp Dermatitis
- What is being tested?
- TD03 and TD07
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- 1 siteVietnam
- Study dates
- 22 May 2019to Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Nationa Hospital of Dermatology
Hanoi, 100000
Phuong Pham Thi Minh, 04.3852.1179
About this study
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)
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.
Read the 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.
- Conditions
- Scalp Dermatitis
- Being tested
- TD03, TD07, Ketoconazole 2% Shampoo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD03Other
Shampoo TD 3 days
TD07Other
Shampoo TD 7 days
Ketoconazole 2% ShampooDrug
Ketoconazole 2% Shampoo
| Study group | Role | What they receive |
|---|---|---|
| TD3 | Experimental | TD3, bi-daily x 4 weeks Receives: Other: TD03 |
| TD7 | Experimental | TD7, bi-daily x 4 weeks Receives: Other: TD07 |
| Ketoconazole 2% | Active comparator | Ketoconazole 2% shampoo bi-daily x 4 weeks Receives: Drug: Ketoconazole 2% Shampoo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
The numbers of subjects with AE/SAE
The numbers of subjects with AE/SAE as defined in the protocol.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start22 May 2019
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scalp DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sao Thai Duong Joint Stock Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Big Leap Research
- Responsible party
- Sponsor
- Investigators
- Phuong TM Pham, Principal investigator, National Hospital of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845348
- Sponsor's protocol ID
- TD0307.03
- Acronym
- TD0307
- Status last verified
- Jun 2022
- First submitted
- 10 Jan 2019
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03845348
- Acronym / sponsor ID
- TD0307 / TD0307.03
- Conditions
- Scalp Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Sao Thai Duong Joint Stock CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Big Leap Research
- Study start
- 22 May 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TD3 | Experimental | Other: TD03TD3, bi-daily x 4 weeks |
| TD7 | Experimental | Other: TD07TD7, bi-daily x 4 weeks |
| Ketoconazole 2% | Active comparator | Drug: Ketoconazole 2% ShampooKetoconazole 2% shampoo bi-daily x 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TD03Shampoo TD 3 days | Other | TD3 |
| TD07Shampoo TD 7 days | Other | TD7 |
| Ketoconazole 2% ShampooKetoconazole 2% Shampoo | Drug | Ketoconazole 2% |
Primary outcome
Change from baseline in IGA scale at 4 week-treatment
Time frame: 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
Time frame: 4 weeks
The numbers of subjects with AE/SAE as defined in the protocol.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Scalp Dermatitis
RecruitingPhase 2
Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome
Atopic Dermatitis, Alopecia Areata
RecruitingEarly Phase 1
The Effectiveness of Itraconazole Pulse Therapy vs Topical 2% Ketoconazole in the Treatment of Moderate to Severe Seborrheic Dermatitis of Scalp.
Seborrheic Dermatitis
Recruiting
A Study on Scalp Health and Integrated Scalp Management Protocols for Hair Transplant Patients
Hair Transplantation, Seborrheic Dermatitis
Active, not recruitingObservational study
Serum 25(OH) Vitamin D and Total Serum Immunoglobulin E Levels in Patients With Pityriasis Alba
Pityriasis Alba
Recruiting
Antidandruff Lotion Mediating Microbiome Rebalance
Dandruff
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phuong TM Pham principal investigator
National Hospital of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TD03 and TD07 in people with Scalp Dermatitis, run by Sao Thai Duong Joint Stock Company at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Van Nguyen Thi Hong, MSC ((+84) 916451269, vannh@thaiduong.com.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in IGA scale at 4 week-treatment (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.