Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551818
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
A Clinical Study to Assess Safety Efficacy and In-use Tolerability of Different Dosages of Hair Growth Products in Patients With Mild to Moderate Androgenic Alopecia Grade I to III
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Interventional Exploratory Four-Arm - Dose Response Study Comparative Double-Blind Randomized Placebo-Control Proof of Concept Safety Efficacy and In-Use Tolerability Study of Three Different Dosage Formulation of Test Hair Growth Products and Placebo 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 a prospective interventional exploratory four-arm - dose response study comparative double-blind randomized placebo-control proof of concept safety efficacy and in-use tolerability study of three different dosage formulation of test hair growth products and placebo in patients with mild to moderate Androgenic Alopecia Grade I to III
Detailed Description:
A total of up to 72 patients 18 patientsarm preferably equal number of male and female will be enrolled to ensure a total of 60 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 01 Day -04 Screening Tattoo creation hair growth measurement Visit 02Day 01Enrolment hair growth rate measurement hair length androgenic affected targeted area and standard area 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 CBC Biochemical tests free testosterone testosterone dihydrotestosterone CRP Cortisol random ferritin urinalysis
Visit 03 Day 45 Hair Length Androgenic Alopecia affected targeted area standard area hair thickness hair density scalp condition for keratin measurement hair regrowth AG affected area number of hair fall from root number of new hairs full scalp and normal scalp- tattoo area 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 90Hair growth rate measurement hair length Androgenic Alopecia affected targeted area and standard area hair thickness hair density scalp condition for keratin measurement A T ratio hair regrowth AG affected area number of new hairs on full scalp normal scalp- tattoo area 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 135Hair length Androgenic Alopecia affected targeted area and standard area hair thickness hair density scalp condition for keratin measurement hair regrowth AG affected area number of hair fall from root number of new hair on full scalp normal scalp- tattoo area 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 Hair growth rate measurement hair length standard area and Androgenic Alopecia affected targeted area hair thickness hair density scalp condition for keratin measurement A T Ratio number of new hair on full scalp AG affected area hair regrowth AG affected area 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 CBC Biochemical tests free testosterone testosterone dihydrotestosterone CRP Cortisol random ferritin urinalysis
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 01 Day -04 Screening Tattoo creation hair growth measurement Visit 02Day 01Enrolment hair growth rate measurement hair length androgenic affected targeted area and standard area 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 CBC Biochemical tests free testosterone testosterone dihydrotestosterone CRP Cortisol random ferritin urinalysis
Visit 03 Day 45 Hair Length Androgenic Alopecia affected targeted area standard area hair thickness hair density scalp condition for keratin measurement hair regrowth AG affected area number of hair fall from root number of new hairs full scalp and normal scalp- tattoo area 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 90Hair growth rate measurement hair length Androgenic Alopecia affected targeted area and standard area hair thickness hair density scalp condition for keratin measurement A T ratio hair regrowth AG affected area number of new hairs on full scalp normal scalp- tattoo area 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 135Hair length Androgenic Alopecia affected targeted area and standard area hair thickness hair density scalp condition for keratin measurement hair regrowth AG affected area number of hair fall from root number of new hair on full scalp normal scalp- tattoo area 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 Hair growth rate measurement hair length standard area and Androgenic Alopecia affected targeted area hair thickness hair density scalp condition for keratin measurement A T Ratio number of new hair on full scalp AG affected area hair regrowth AG affected area 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 CBC Biochemical tests free testosterone testosterone dihydrotestosterone CRP Cortisol random ferritin urinalysis
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