Exosome Effect on Prevention of Hairloss

NCT05658094 | Unknown

• 1 other identifier: Isfahan Med Uni
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hair Loss; Alopecia

Keywords

Exosome

Outcome Measures

Primary Outcomes (4)

• Change in mean total hair density (hair/cm2)

  Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm\^2)

  0 months

• Change in mean total hair density (hair/cm2)

  Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm\^2)

  3 months

• Change in mean total hair density (hair/cm2)

  Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm\^2)

  6 months

• visual assessment before and after

  Visual Assessment using the clinical picture by a general physician

  6 months

Secondary Outcomes (3)

• Change in mean Telogen and Anagen hair density

  0, months

• Change in mean Telogen and Anagen hair density

  3 months

• Change in mean Telogen and Anagen hair density

  6 months

Study Arms (1)

Exosome

EXPERIMENTAL

Exosome (100e10 particle) injections with an interval of 14 days during two months.

Device: Exosome

Interventions

Exosome DEVICE

Each patients will receive 4 injection with an interval of 14 days during two months

Also known as: Extracellular Vesicle

Exosome

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Leila Dehghani

Isfahan, 8179997781, Iran

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

leila dehghani, Dr

CONTACT

+393517261300; l_dehghani2002@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Leila Dehghani

Study Record Dates

• First Submitted: November 5, 2022
• First Posted: December 20, 2022
• Study Start: August 1, 2022
• Primary Completion: May 29, 2023
• Study Completion: October 29, 2023
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

IR (1)