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

  • STATUS
    Recruiting
  • End date
    Jun 21, 2023
  • participants needed
    366
  • sponsor
    Sunstar Joint Stock Company
Updated on 21 September 2021

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.

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.

Details
Condition Scalp Dermatitis
Treatment TD03, TD07, Ketoconazole 2% Shampoo
Clinical Study IdentifierNCT03845348
SponsorSunstar Joint Stock Company
Last Modified on21 September 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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