Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06556056
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
An Exploratory Clinical Study to Assess Safety Efficacy and In-Use Tolerability of Three Different Hair Growth Products in Patients With Mild to Moderate Androgenic Alopecia Grade I to III
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exploratory Prospective Three-arm Interventional Comparative Randomized Double-blind Placebo-controlled Safety Efficacy and In-use Tolerability Study of Hair Growth Products in Patients With Mild to Moderate Androgenic Alopecia Grade I to III
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an exploratory prospective three-arm interventional comparative randomized double-blind placebo-controlled safety efficacy and in-use tolerability study of hair growth products in the patients mild to moderate androgenic alopecia Grade I to III
Detailed Description:
A total of up to 54 patients 18 patientsarm preferably equal number of male and female will be enrolled to ensure a total of 45 patients 15 patients arm to complete the study
There will be total of 8 visits during the study The duration of the study will be 180 days 6 months from the enrolment
visit 1Day -04 Screening Tattoo creation hair growth measurement Visit 02Day 01 Enrolment hair growth rate measurement hair length hair thickness hair density scalp condition for keratin measurement A T ratio number of new hairs number of hair fall from root hair root strength general appearance of hair general appearance of scalp earlier product perception questionnaire global pictures of head crown
Visit 03 Day 45 Hair Length hair thickness hair density scalp condition for keratin measurement hair regrowth number of hair fall from root number of new hairs from the full scalp AG affected hair root strength general appearance of hair general appearance of scalp product perception questionnaire global pictures of head crown
Visit 04 Day 87 Tattoo creation hair growth measurement Visit 05 Day 90 03 days from visit 04Hair growth rate measurement hair length hair thickness hair density scalp condition for keratin measurement A T ratio hair regrowth number of new hairs number of hair fall from root hair root strength general appearance of hair general appearance of scalp product perception questionnaire digital photographs of global pictures head crown
Visit 06 Day 135 Hair length hair thickness hair density scalp condition for keratin measurement hair regrowth number of hair fall from root number of new hair hair root strength from root general appearance of hair general appearance of scalp product perception questionnaire digital photographs of global pictures head crown
Visit 07 Day 177 Tattoo creation hair growth measurement Visit 08 Day 180 03 days from Visit 07 Hair growth rate measurement hair length hair thickness hair density scalp condition for keratin measurement A T Ratio number of new hair hair regrowth number of hair fall from root hair root strength general appearance of hair general appearance of scalp product perception questionnaire global pictures of head crown
There will be total of 8 visits during the study The duration of the study will be 180 days 6 months from the enrolment
visit 1Day -04 Screening Tattoo creation hair growth measurement Visit 02Day 01 Enrolment hair growth rate measurement hair length hair thickness hair density scalp condition for keratin measurement A T ratio number of new hairs number of hair fall from root hair root strength general appearance of hair general appearance of scalp earlier product perception questionnaire global pictures of head crown
Visit 03 Day 45 Hair Length hair thickness hair density scalp condition for keratin measurement hair regrowth number of hair fall from root number of new hairs from the full scalp AG affected hair root strength general appearance of hair general appearance of scalp product perception questionnaire global pictures of head crown
Visit 04 Day 87 Tattoo creation hair growth measurement Visit 05 Day 90 03 days from visit 04Hair growth rate measurement hair length hair thickness hair density scalp condition for keratin measurement A T ratio hair regrowth number of new hairs number of hair fall from root hair root strength general appearance of hair general appearance of scalp product perception questionnaire digital photographs of global pictures head crown
Visit 06 Day 135 Hair length hair thickness hair density scalp condition for keratin measurement hair regrowth number of hair fall from root number of new hair hair root strength from root general appearance of hair general appearance of scalp product perception questionnaire digital photographs of global pictures head crown
Visit 07 Day 177 Tattoo creation hair growth measurement Visit 08 Day 180 03 days from Visit 07 Hair growth rate measurement hair length hair thickness hair density scalp condition for keratin measurement A T Ratio number of new hair hair regrowth number of hair fall from root hair root strength general appearance of hair general appearance of scalp product perception questionnaire global pictures of head crown
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None