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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-22

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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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

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Scalp Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TD3

TD3, bi-daily x 4 weeks

Group Type EXPERIMENTAL

TD03

Intervention Type OTHER

Shampoo TD 3 days

TD7

TD7, bi-daily x 4 weeks

Group Type EXPERIMENTAL

TD07

Intervention Type OTHER

Shampoo TD 7 days

Ketoconazole 2%

Ketoconazole 2% shampoo bi-daily x 4 weeks

Group Type ACTIVE_COMPARATOR

Ketoconazole 2% Shampoo

Intervention Type DRUG

Ketoconazole 2% Shampoo

Interventions

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TD03

Shampoo TD 3 days

Intervention Type OTHER

TD07

Shampoo TD 7 days

Intervention Type OTHER

Ketoconazole 2% Shampoo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No