Back to resultsExosome Effect on Prevention of Hairloss
Primary Purpose
Hair Loss, Alopecia
Status
Recruiting
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Exosome
Sponsored by
About this trial
This is an interventional prevention trial for Hair Loss focused on measuring Exosome
Eligibility Criteria
Inclusion Criteria: subjects able to read the documents and have medical coverage Subjects have a "hair loss grade" as below criteria: BASP grade: Basic type (M2 to M3, or C2 to C3, or U1 to U3) or Specific type (V1 to V3, or F1 to F3) For female: Ludwig grade: Ⅰ to Ⅱ For male: Norwood-Hamilton grade: III to IV Hair density by phototrichogram: 60 to 190 hair/cm2 Telogen hair ≥ 5% Subject agreeing not to apply any topical treatment Subject agreeing to use a neutral shampoo Exclusion Criteria: Sick subject in situation of emergency. Subjects who have hereditary history of hairloss Pregnant Females Subject using topic cosmetic treatment or oral nutritional supplement likely to interfere on hair loss parameters during the last 3 months prior to the start of the study (screening) Subjects who have a medical treatment for alopecia or having stopped it from than 3 months
Sites / Locations
- Leila DehghaniRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exosome
Arm Description
Exosome (100e10 particle) injections with an interval of 14 days during two months.
Outcomes
Primary Outcome Measures
Change in mean total hair density (hair/cm2)
Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2)
Change in mean total hair density (hair/cm2)
Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2)
Change in mean total hair density (hair/cm2)
Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2)
visual assessment before and after
Visual Assessment using the clinical picture by a general physician
Secondary Outcome Measures
Change in mean Telogen and Anagen hair density
Measurement of telogen and Anagen hair density before and after trial
Change in mean Telogen and Anagen hair density
Measurement of telogen and Anagen hair density before and after trial
Change in mean Telogen and Anagen hair density
Measurement of telogen and Anagen hair density before and after trial
Full Information
NCT ID
NCT05658094
First Posted
November 5, 2022
Last Updated
December 17, 2022
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05658094
Brief Title
Exosome Effect on Prevention of Hairloss
Official Title
Placental Mesenchymal Stem Cells-derived Exosome for Hairloss
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
May 29, 2023 (Anticipated)
Study Completion Date
October 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Many people suffer from alopecia, which is caused by hereditary factors, emotional stress, and psychiatric disorders. There are devastating physical and psychological consequences as a result. Exosomes are isolated from donated human amniotic mesenchymal stem cells and purified using specific processing. Exosomes are unique in that they are derived from stem cells and contain a wide range of growth factors. The latest generation of natural products for treating hair loss is exosomes.
Detailed Description
Exosomes contain a variety of growth factors that are derived from stem cells. As they are so small, they can be hidden in the bloodstream and carry different types of proteins.
The Wnt-β-catenin pathway is thought to play a major role in the pathogenesis of hair loss. The only FDA-approved medications for the treatment of hair loss are minoxidil (a vasodilator) and finasteride (a selective inhibitor of 5α reductase type II and III isoforms). However, these drugs have not been very perfect. Both have been associated with limited efficacy, duration of effect, and several significant side effects. Regenerative medicine using cell products is looking for a way to heal faster and less cost. Present research focus on Exosome efficacy on hairloss.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hair Loss, Alopecia
Keywords
Exosome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exosome
Arm Type
Experimental
Arm Description
Exosome (100e10 particle) injections with an interval of 14 days during two months.
Intervention Type
Device
Intervention Name(s)
Exosome
Other Intervention Name(s)
Extracellular Vesicle
Intervention Description
Each patients will receive 4 injection with an interval of 14 days during two months
Primary Outcome Measure Information:
Title
Change in mean total hair density (hair/cm2)
Description
Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2)
Time Frame
0 months
Title
Change in mean total hair density (hair/cm2)
Description
Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2)
Time Frame
3 months
Title
Change in mean total hair density (hair/cm2)
Description
Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2)
Time Frame
6 months
Title
visual assessment before and after
Description
Visual Assessment using the clinical picture by a general physician
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in mean Telogen and Anagen hair density
Description
Measurement of telogen and Anagen hair density before and after trial
Time Frame
0, months
Title
Change in mean Telogen and Anagen hair density
Description
Measurement of telogen and Anagen hair density before and after trial
Time Frame
3 months
Title
Change in mean Telogen and Anagen hair density
Description
Measurement of telogen and Anagen hair density before and after trial
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
subjects able to read the documents and have medical coverage
Subjects have a "hair loss grade" as below criteria:
BASP grade: Basic type (M2 to M3, or C2 to C3, or U1 to U3) or Specific type (V1 to V3, or F1 to F3)
For female: Ludwig grade: Ⅰ to Ⅱ
For male: Norwood-Hamilton grade: III to IV
Hair density by phototrichogram: 60 to 190 hair/cm2
Telogen hair ≥ 5% Subject agreeing not to apply any topical treatment Subject agreeing to use a neutral shampoo
Exclusion Criteria:
Sick subject in situation of emergency.
Subjects who have hereditary history of hairloss
Pregnant Females
Subject using topic cosmetic treatment or oral nutritional supplement likely to interfere on hair loss parameters during the last 3 months prior to the start of the study (screening)
Subjects who have a medical treatment for alopecia or having stopped it from than 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
leila dehghani, Dr
Phone
+393517261300
Email
l_dehghani2002@yahoo.com
Facility Information:
Facility Name
Leila Dehghani
City
Isfahan
ZIP/Postal Code
8179997781
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
leila dehghani
Phone
+393517261300
Email
l_dehghani2002@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Exosome Effect on Prevention of Hairloss
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