To Evaluate the Efficacy and Safety of Shampoo TD03 and TD07 in Scalp Diseases (TD0307)

Sao Thai Duong

Status and phase: Enrolling; Phase 3

Conditions: Scalp Dermatitis

Treatments: Drug: Ketoconazole 2% Shampoo; Other: TD03; Other: TD07

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03845348

TD0307.03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 366 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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366 participants in 3 patient groups

TD3

Experimental group

Description:

TD3, bi-daily x 4 weeks

Treatment:

Other: TD03

TD7

Experimental group

Description:

TD7, bi-daily x 4 weeks

Treatment:

Other: TD07

Ketoconazole 2%

Active Comparator group

Description:

Ketoconazole 2% shampoo bi-daily x 4 weeks

Treatment:

Drug: Ketoconazole 2% Shampoo