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

Last updated: October 25, 2022
Sponsor: Sao Thai Duong Joint Stock Company
Overall Status: Active - Recruiting

Phase

3

Condition

Allergy

Eczema (Atopic Dermatitis - Pediatric)

Scalp Disorders

Treatment

N/A

Clinical Study ID

NCT03845348
TD0307.03
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Use oral antifungal 1 month prior to the trial participation or topical antifungal 2weeks prior to the trial participation.
  • Suffering chronic or acute diseases that may affect the trial.

Study Design

Total Participants: 366
Study Start date:
May 22, 2019
Estimated Completion Date:
June 30, 2023

Study 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.

Connect with a study center

  • Nationa Hospital of Dermatology

    Hanoi, 100000
    Vietnam

    Active - Recruiting

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