Ignite Creation Date:
2024-07-17 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482541
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
Efficacy and Safety Of AGE ZERO EXOSOMES To Treat Men and Women With Androgenetic Alopecia
Sponsor:
Levit Dermatology
Organization:
Levit Dermatology
Study Overview
Official Title:
1-Year Double-Blind Placebo-Controlled Study To EVALUATE THE EFFECT OF AGE ZERO EXOSOMES ON HAIR REGROWTH IN HEALTHY MEN AND WOMEN WITH ANDROGENETIC ALOPECIA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 purpose of this study is to determine whether Whartons Jelly mesenchymal stem cell-derived exosome microneedling on the scalp is an effective treatment for Androgenetic Alopecia pattern hair loss
Detailed Description:
After being informed about the study and potential risks all participants who give written consent and meet the later discussed inclusion criteria and dont fall under the exclusion criteria will be enrolled in the study
The investigators will conduct a double-blind placebo-controlled study to test whether Whartons Jelly Mesenchymal Stem Cell-derived Exosome WJMSC-exosome application with microneedling is an effective treatment for Androgenetic Alopecia Participants will be broken down into a 5 billion exosome group vs saline group and a 50 billion exosome vs saline group
Treatment will be applied to the following treatment area two rectangles on the scalp vertex each measuring 4cm on the sagittal plane by 2cm on the coronal plane One rectangle will be 20 mm left of the midline of the scalp and another will be 20 mm right of the midline of the scalp Each treatment area will be divided into an anterior and posterior half with 1 permanent microdot tattoo in the middle 4 tattoos in total The microdot tattoo composed of Iron Oxide Glycerol Alcohol and distilled Water and Red - DC Red 30 Glycerol Alcohol and distilled water will allow HairMatrix by Canfield an AI-driven hair consultation device to accurately and reproducibly access changes in hair growth in the treatment areas
Participants in the 5 billion exosome group will receive topical applications of 5 billion WJMSC-exosomes on one side of the treatment area and an equal volume of placebo an identically-looking saline solution application on the opposite side of the treatment area
The 50 billion exosome group will receive topical applications of 50 billion WJMSC-exosomes on one side of the treatment area and an equal volume of placebo application on the opposite side of the treatment area
Immediately after topical application all participants will receive microneedling at a depth of 5 mm on the entire treatment area
Treatment will be administered in 4 sessions monthly for the first three months and for a 4th time 4 months after the third session
The study will go on for 12 months from the date of the first treatment Participants changes in hair growth hair count hair thickness and hair color and adverse events will be evaluated and recorded
The investigators will conduct a double-blind placebo-controlled study to test whether Whartons Jelly Mesenchymal Stem Cell-derived Exosome WJMSC-exosome application with microneedling is an effective treatment for Androgenetic Alopecia Participants will be broken down into a 5 billion exosome group vs saline group and a 50 billion exosome vs saline group
Treatment will be applied to the following treatment area two rectangles on the scalp vertex each measuring 4cm on the sagittal plane by 2cm on the coronal plane One rectangle will be 20 mm left of the midline of the scalp and another will be 20 mm right of the midline of the scalp Each treatment area will be divided into an anterior and posterior half with 1 permanent microdot tattoo in the middle 4 tattoos in total The microdot tattoo composed of Iron Oxide Glycerol Alcohol and distilled Water and Red - DC Red 30 Glycerol Alcohol and distilled water will allow HairMatrix by Canfield an AI-driven hair consultation device to accurately and reproducibly access changes in hair growth in the treatment areas
Participants in the 5 billion exosome group will receive topical applications of 5 billion WJMSC-exosomes on one side of the treatment area and an equal volume of placebo an identically-looking saline solution application on the opposite side of the treatment area
The 50 billion exosome group will receive topical applications of 50 billion WJMSC-exosomes on one side of the treatment area and an equal volume of placebo application on the opposite side of the treatment area
Immediately after topical application all participants will receive microneedling at a depth of 5 mm on the entire treatment area
Treatment will be administered in 4 sessions monthly for the first three months and for a 4th time 4 months after the third session
The study will go on for 12 months from the date of the first treatment Participants changes in hair growth hair count hair thickness and hair color and adverse events will be evaluated and recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None