Ignite Creation Date:
2025-12-24 @ 1:53 AM
Ignite Modification Date:
2025-12-24 @ 1:53 AM
Study NCT ID:
NCT07292467
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-12-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Benefits of Shampoo During 4 Weeks of Treatment and After 24 Weeks
Sponsor:
Vichy Laboratoires
Organization:
Study Overview
Official Title:
Evaluation of the Benefits of Shampoo During 4 Weeks of Treatment and After 24 Weeks With 1 Application Per Week (Maintenance Phase) on Subjects With Moderate to Severe Dandruff and Severe Itching State.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study to evaluate the efficacy of shampoo after 4 weeks (treatment phase) and after 5 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks with 1 application per week (maintenance phase) on subjects with moderate to severe dandruff and severe itching state.
Participants will:
Apply investigationnal products 3 time a week during 4 weeks and investigational product once a week and neutral product twice a week during 24 weeks Visit the center 10 times during the study for evaluations Keep a diary of their discomfort and the number of times they use the investigational products
Participants will:
Apply investigationnal products 3 time a week during 4 weeks and investigational product once a week and neutral product twice a week during 24 weeks Visit the center 10 times during the study for evaluations Keep a diary of their discomfort and the number of times they use the investigational products
Detailed Description:
=\> after 4 weeks (treatment phase) and 5 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks with 1 application per week (maintenance phase)
Primary objective :
• To evaluate the reduction of total dandruff ( adherent and non-adherent)
Secondary objectives:
* To evaluate the Quality of Life (QoL) evolution
* To evaluate the reduction of discomfort (itching, stinging, burning sensation)
* To evaluate the reduction of scales
* To assess the cosmetic properties of investigational product
* To assess the tolerance of investigational product
Primary objective :
• To evaluate the reduction of total dandruff ( adherent and non-adherent)
Secondary objectives:
* To evaluate the Quality of Life (QoL) evolution
* To evaluate the reduction of discomfort (itching, stinging, burning sensation)
* To evaluate the reduction of scales
* To assess the cosmetic properties of investigational product
* To assess the tolerance of investigational product
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: