Hair LossNCT05658094
Exosome Effect on Prevention of Hairloss
A study testing Exosome in people with Hair Loss and Alopecia, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Exosome
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- 1 Aug 2022to 29 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Leila Dehghani
Isfahan, 8179997781
leila dehghani, +393517261300, l_dehghani2002@yahoo.com
About this study
Official title: Placental Mesenchymal Stem Cells-derived Exosome for Hairloss
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.
Read the 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.
- Being tested
- Exosome
- Keywords
- Exosome
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExosomeDevice
Also called Extracellular Vesicle
Each patients will receive 4 injection with an interval of 14 days during two months
| Study group | Role | What they receive |
|---|---|---|
| Exosome | Experimental | Exosome (100e10 particle) injections with an interval of 14 days during two months. Receives: Device: Exosome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean total hair density (hair/cm2)
Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2)
Measured: 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)
Measured: 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)
Measured: 6 months
visual assessment before and after
Visual Assessment using the clinical picture by a general physician
Measured: 6 months
Secondary outcomes (3)
Change in mean Telogen and Anagen hair density
Measurement of telogen and Anagen hair density before and after trial
Measured: 0, months
Change in mean Telogen and Anagen hair density
Measurement of telogen and Anagen hair density before and after trial
Measured: 3 months
Change in mean Telogen and Anagen hair density
Measurement of telogen and Anagen hair density before and after trial
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 Aug 2022
- Primary completion29 May 2023 (estimated)
- Study completion29 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Dehghani, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658094
- Sponsor's protocol ID
- Isfahan Med Uni
- Status last verified
- Dec 2022
- First submitted
- 5 Nov 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Mesenchymal Stem Cells-derived Exosome for Hairloss
- ClinicalTrials.gov ID
- NCT05658094
- Acronym / sponsor ID
- Isfahan Med Uni
- Keywords
- Exosome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 29 May 2023 (estimated)
- Study completion
- 29 Oct 2023 (estimated)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exosome | Experimental | Device: ExosomeExosome (100e10 particle) injections with an interval of 14 days during two months. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- subjects able to read the documents and have medical coverage
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExosomeAlso: Extracellular VesicleEach patients will receive 4 injection with an interval of 14 days during two months | Device | Exosome |
Primary outcome
Change in mean total hair density (hair/cm2)
Time frame: 0 months
Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2)
Change in mean total hair density (hair/cm2)
Time frame: 3 months
Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2)
Change in mean total hair density (hair/cm2)
Time frame: 6 months
Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2)
visual assessment before and after
Time frame: 6 months
Visual Assessment using the clinical picture by a general physician
3 secondary outcomes
Change in mean Telogen and Anagen hair density
Time frame: 0, months
Change in mean Telogen and Anagen hair density
Time frame: 3 months
Change in mean Telogen and Anagen hair density
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exosome in people with Hair Loss and Alopecia, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact leila dehghani, Dr (+393517261300, l_dehghani2002@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean total hair density (hair/cm2) (time frame: 0 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.