Alopecia AndrogenicaexosomeNCT06930326
Exosome Treatment and Hair Growth
A study testing intradermal exosome and 0.9 % NaCl in people with Alopecia Androgenica, run by COSMEDICIAN AP SDN BHD at 1 site in Malaysia.
Trial summary
This study investigates a novel exosome-based plant formulation for treating male pattern baldness (androgenetic alopecia), a condition that affects self-esteem and well-being. Current treatments like minoxidil and finasteride offer limited effectiveness and may cause side effects, increasing demand for safer, more… Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alopecia Androgenica
- What is being tested?
- intradermal exosome and 0.9 % NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Nov 2022to 28 Jun 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Norwood grade 2-3 androgenic alopecia among male Malaysians.
- Aged between 20 and 50 years.
- Demonstrated the ability to comprehend the study protocol and information provided by the investigators.
- Participants willing to give informed consent.
Who cannot join
- Pre-existing thyroid disorders, bleeding disorders, or diabetes.
- Current use of any medical hair treatment.
- Corticosteroid or immunosuppressive drug use.
- Alopecia classified as Norwood scale 1, 4, 5, 6, 7, or cicatricial alopecia.
- Smoking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Triple-blind Comparative Study of Exosome and Exosomes-containing Formulation Versus Placebo in Treating Alopecia
This study investigates a novel exosome-based plant formulation for treating male pattern baldness (androgenetic alopecia), a condition that affects self-esteem and well-being. Current treatments like minoxidil and finasteride offer limited effectiveness and may cause side effects, increasing demand for safer, more effective alternatives. Exosomes, small extracellular vesicles that facilitate cell repair and communication, show promise in promoting hair regeneration. Botanical extracts, such as Ecklonia cava (brown seaweed) and Thuja orientalis (medicinal plant), have also demonstrated hair growth benefits. This study combines these components into a single formulation to enhance therapeutic outcomes.
A randomized, double-blind, placebo-controlled trial is conducted to evaluate the efficacy of this exosome-containing formulation. The study enrolls 20 male participants aged 18 to 35 with Norwood 2-3 androgenetic alopecia. Participants are randomly assigned to receive either the exosome treatment (containing 10 billion exosomes with Ecklonia cava and Thuja orientalis extracts) or a placebo (0.9% sodium chloride). The treatment is administered through four biweekly sessions of intradermal scalp injections, performed by a certified aesthetic physician under strict aseptic conditions.
Hair growth is assessed using standardized photography, trichoscopic imaging, and hair density measurements, with a blinded medical assessor ensuring objective evaluation. Additionally, participants complete self-reported satisfaction surveys to gauge perceived effectiveness. Strict ethical guidelines are followed, including informed consent and exclusion of individuals with underlying medical conditions, recent hair treatments, or lifestyle factors that could influence results. The study aims to provide scientific evidence on the safety and efficacy of this exosome-based therapy as a potential alternative for hair restoration.
- Conditions
- Alopecia Androgenica
- Being tested
- intradermal exosome, 0.9 % NaCl
- Keywords
- Alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intradermal exosomeOther
The solution was drawn into five 1 mL tuberculin syringes, each fitted to a 30-gauge short needle. Intradermal injections of 0.05 to 0.1 mL per site were administered at approximately 1 cm apart, delivering a total volume of 5 mL per session.
0.9 % NaClOther
The solution was drawn into five 1 mL tuberculin syringes, each fitted to a 30-gauge short needle. Intradermal injections of 0.05 to 0.1 mL per site were administered at approximately 1 cm apart, delivering a total volume of 5 mL per session.
| Study group | Role | What they receive |
|---|---|---|
| Control group (Group A), which received 0.9% sodium chloride | Placebo comparator | Not described Receives: Other: 0.9 % NaCl |
| Intervention group (Group B), received an Exosome-Containing Plant Extract Formulation | Experimental | Not described Receives: Other: intradermal exosome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trichoscopic parameters: Total Hair Density
High-resolution trichoscopic images were captured using the Dino-Lite Trichoscope (Dino-Lite Europe, Almere, The Netherlands) at a standardized anatomical reference point, defined as the intersection of a vertical line descending from the lateral canthus of one eye (left or right) and a horizontal coronal line connecting both ears. Images were taken over two circular scalp areas, each with a diameter of 0.5 cm.
These images were analyzed using Trichoscale Pro® software, which enables precise automated quantification of scalp structures. All measurements were subsequently verified manually by a blinded medical assessor to ensure accuracy.
Total hair density was assessed as a primary parameter, with results expressed in hairs per square centimeter (hairs/cm²).
The assessments were performed at baseline, 12, and 16 weeks post-treatment.
Measured: Baseline, 12, and 16 weeks post-treatment
Modified global photographic assessment score (MGPA)
Canon EOS 200D II digital camera (Canon, Taichung, Taiwan, China) was used for standardized profile photography, capturing lateral, facial, occipital, and cephalic views. The modified global photographic assessment score (MGPA) was used with the standardized 7-point rating score using scalp photographs: 1, significant disease progression; 2, moderate disease progression; 3, slight disease progression; 4, no change; 5, slight improvement; 6, moderate improvement; and 7, significant improvement. The scalp photographs of the subjects was evaluation of MGPA by blinded medical assessor. The assessments were performed at baseline, 12, and 16 weeks post-treatment.
Measured: Baseline, 12 weeks, and 16 weeks post-treatment.
Secondary outcomes (5)
Hair Growth Satisfaction Scale (HGSS)
Participants' self-perceived satisfaction with overall hair growth improvement will be evaluated using a Hair Growth Satisfaction Scale (HGSS) with Scale Range: 1 to 5.
Scale Description:
- = Strongly Disagree
- = Disagree
- = Neutral
- = Agree
- = Strongly Agree Interpretation: Higher scores reflect greater participant satisfaction with hair growth results. A total satisfaction score (range: 5 to 25) will be computed by summing all item scores.
Measured: Baseline, and week 16
Trichoscopic parameters: Number of Empty Follicles
High-resolution trichoscopic images were obtained using the Dino-Lite Trichoscope (Dino-Lite Europe, Almere, The Netherlands) at a standardized anatomical reference point, defined as the intersection of a vertical line descending from the lateral canthus of one eye (either left or right) and a horizontal coronal line connecting both ears. Imaging was performed over two circular scalp areas, each with a diameter of 0.5 cm.
The number of empty follicles was assessed. Image analysis was performed through manual verification by a blinded medical assessor to ensure accuracy. Results were expressed as the count of empty follicles per 0.5 cm circular area.
The assessments were performed at baseline, 12, and 16 weeks post-treatment.
Measured: The assessments were performed at baseline, 12, and 16 weeks post-treatment.
Trichoscopic Parameter: Percentage of Follicles with Peripilar Sign
High-resolution trichoscopic images were acquired using the Dino-Lite Trichoscope (Dino-Lite Europe, Almere, The Netherlands) at a standardized anatomical reference point, defined as the intersection of a vertical line extending from the lateral canthus of one eye (left or right) and a horizontal coronal line connecting both ears. Imaging was conducted over two circular scalp areas, each with a diameter of 0.5 cm.
The percentage of follicles exhibiting the peripilar sign was evaluated. Visual scoring was performed on the trichoscopic images, with manual verification carried out by a blinded medical assessor to ensure measurement consistency. Results were reported as the proportion (%) of observed follicles displaying the peripilar sign.
The assessments were performed at baseline, 12, and 16 weeks post-treatment.
Measured: The assessments were performed at baseline, 12, and 16 weeks post-treatment.
Trichoscopic Parameter: Presence of Honeycomb Pigment Pattern (HCPP)
High-resolution trichoscopic images were obtained using the Dino-Lite Trichoscope (Dino-Lite Europe, Almere, The Netherlands) at a standardized anatomical reference point, defined as the intersection of a vertical line extending from the lateral canthus of one eye (left or right) and a horizontal coronal line connecting both ears. Imaging was performed over two circular scalp areas, each with a diameter of 0.5 cm.
The presence of the Honeycomb Pigment Pattern (HCPP) was assessed. Visual evaluation was conducted on the trichoscopic images by a blinded medical assessor to ensure consistency and objectivity. Results were reported in binary format as either present or absent.
Assessments were conducted at baseline, 12 weeks, and 16 weeks post-treatment.
Measured: Assessments were conducted at baseline, 12 weeks, and 16 weeks post-treatment.
Trichoscopic Parameter: Presence of Fibrosis
High-resolution trichoscopic images were captured using the Dino-Lite Trichoscope (Dino-Lite Europe, Almere, The Netherlands) at a standardized anatomical reference point, defined as the intersection of a vertical line extending from the lateral canthus of one eye (left or right) and a horizontal coronal line connecting both ears. Imaging was performed over two circular scalp areas, each with a diameter of 0.5 cm.
The presence of follicular fibrosis was evaluated. Visual assessment was conducted using the trichoscopic images, with evaluations performed by a blinded medical assessor to ensure accuracy and minimize bias. Results were recorded in a binary format as either present or absent.
Assessments were carried out at baseline, 12 weeks, and 16 weeks post-treatment.
Measured: Assessments were carried out at baseline, 12 weeks, and 16 weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 Nov 2022
- Primary completion5 Apr 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AndrogenicaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- COSMEDICIAN AP SDN BHD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Associate Professor Dr. Edmond Ng Siah Chye, Principal investigator, School of Healthy Ageing, Aesthetics & Regenerative Medicine, Faculty of Medicine and Health Sciences, UCSI University, Kuala Lumpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930326
- Sponsor's protocol ID
- UCSI-IEC-2022-FMHS-062.
- Acronym
- exosome
- Status last verified
- Apr 2025
- First submitted
- 24 Mar 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analyzed during the current study are available from the corresponding authors on reasonable request. All of the individual participant data collected during the trial, after deidentification, will be shared upon reasonable request. Additional documents including study protocols, statistical analysis plans, informed consent forms, and clinical study reports will also be made available. The data will be available immediately following publication, with no end date. The data will be shared with anyone who wishes to access them on reasonable request. The data can be used for any type of analysis.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Triple-blind Comparative Study of Exosome and Exosomes-containing Formulation Versus Placebo in Treating Alopecia
- ClinicalTrials.gov ID
- NCT06930326
- Acronym / sponsor ID
- exosome / UCSI-IEC-2022-FMHS-062.
- Conditions
- Alopecia Androgenica
- Keywords
- Alopecia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- COSMEDICIAN AP SDN BHDIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 16 Apr 2025 (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.
This study investigates a novel exosome-based plant formulation for treating male pattern baldness (androgenetic alopecia), a condition that affects self-esteem and well-being. Current treatments like minoxidil and finasteride offer limited effectiveness and may cause side effects, increasing demand for safer, more effective alternatives. Exosomes, small extracellular vesicles that facilitate cell repair and communication, show promise in promoting hair regeneration. Botanical extracts, such as Ecklonia cava (brown seaweed) and Thuja orientalis (medicinal plant), have also demonstrated hair growth benefits. This study combines these components into a single formulation to enhance therapeutic outcomes.
A randomized, double-blind, placebo-controlled trial is conducted to evaluate the efficacy of this exosome-containing formulation. The study enrolls 20 male participants aged 18 to 35 with Norwood 2-3 androgenetic alopecia. Participants are randomly assigned to receive either the exosome treatment (containing 10 billion exosomes with Ecklonia cava and Thuja orientalis extracts) or a placebo (0.9% sodium chloride). The treatment is administered through four biweekly sessions of intradermal scalp injections, performed by a certified aesthetic physician under strict aseptic conditions.
Hair growth is assessed using standardized photography, trichoscopic imaging, and hair density measurements, with a blinded medical assessor ensuring objective evaluation. Additionally, participants complete self-reported satisfaction surveys to gauge perceived effectiveness. Strict ethical guidelines are followed, including informed consent and exclusion of individuals with underlying medical conditions, recent hair treatments, or lifestyle factors that could influence results. The study aims to provide scientific evidence on the safety and efficacy of this exosome-based therapy as a potential alternative for hair restoration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (Group A), which received 0.9% sodium chloride | Placebo comparator | Other: 0.9 % NaCl |
| Intervention group (Group B), received an Exosome-Containing Plant Extract Formulation | Experimental | Other: intradermal exosome |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Norwood grade 2-3 androgenic alopecia among male Malaysians.
- Aged between 20 and 50 years.
- Demonstrated the ability to comprehend the study protocol and information provided by the investigators.
- Participants willing to give informed consent.
Key exclusion criteria (5 listed)
- Pre-existing thyroid disorders, bleeding disorders, or diabetes.
- Current use of any medical hair treatment.
- Corticosteroid or immunosuppressive drug use.
- Alopecia classified as Norwood scale 1, 4, 5, 6, 7, or cicatricial alopecia.
- Smoking.
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 |
|---|---|---|
| intradermal exosomeThe solution was drawn into five 1 mL tuberculin syringes, each fitted to a 30-gauge short needle. Intradermal injections of 0.05 to 0.1 mL per site were administered at approximately 1 cm apart, delivering a total volume of 5 mL per session. | Other | Intervention group (Group B), received an Exosome-Containing Plant Extract Formulation |
| 0.9 % NaClThe solution was drawn into five 1 mL tuberculin syringes, each fitted to a 30-gauge short needle. Intradermal injections of 0.05 to 0.1 mL per site were administered at approximately 1 cm apart, delivering a total volume of 5 mL per session. | Other | Control group (Group A), which received 0.9% sodium chloride |
Primary outcome
Trichoscopic parameters: Total Hair Density
Time frame: Baseline, 12, and 16 weeks post-treatment
High-resolution trichoscopic images were captured using the Dino-Lite Trichoscope (Dino-Lite Europe, Almere, The Netherlands) at a standardized anatomical reference point, defined as the intersection of a vertical line descending from the lateral canthus of one eye (left or right) and a horizontal coronal line connecting both ears. Images were taken over two circular scalp areas, each with a diameter of 0.5 cm. These images were analyzed using Trichoscale Pro® software, which enables precise automated quantification of scalp structures. All measurements were subsequently verified manually by a blinded medical assessor to ensure accuracy. Total hair density was assessed as a primary parameter, with results expressed in hairs per square centimeter (hairs/cm²). The assessments were performed at baseline, 12, and 16 weeks post-treatment.
Modified global photographic assessment score (MGPA)
Time frame: Baseline, 12 weeks, and 16 weeks post-treatment.
Canon EOS 200D II digital camera (Canon, Taichung, Taiwan, China) was used for standardized profile photography, capturing lateral, facial, occipital, and cephalic views. The modified global photographic assessment score (MGPA) was used with the standardized 7-point rating score using scalp photographs: 1, significant disease progression; 2, moderate disease progression; 3, slight disease progression; 4, no change; 5, slight improvement; 6, moderate improvement; and 7, significant improvement. The scalp photographs of the subjects was evaluation of MGPA by blinded medical assessor. The assessments were performed at baseline, 12, and 16 weeks post-treatment.
5 secondary outcomes
Hair Growth Satisfaction Scale (HGSS)
Time frame: Baseline, and week 16
Trichoscopic parameters: Number of Empty Follicles
Time frame: The assessments were performed at baseline, 12, and 16 weeks post-treatment.
Trichoscopic Parameter: Percentage of Follicles with Peripilar Sign
Time frame: The assessments were performed at baseline, 12, and 16 weeks post-treatment.
Trichoscopic Parameter: Presence of Honeycomb Pigment Pattern (HCPP)
Time frame: Assessments were conducted at baseline, 12 weeks, and 16 weeks post-treatment.
Trichoscopic Parameter: Presence of Fibrosis
Time frame: Assessments were carried out at baseline, 12 weeks, and 16 weeks post-treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analyzed during the current study are available from the corresponding authors on reasonable request. All of the individual participant data collected during the trial, after deidentification, will be shared upon reasonable request. Additional documents including study protocols, statistical analysis plans, informed consent forms, and clinical study reports will also be made available. The data will be available immediately following publication, with no end date. The data will be shared with anyone who wishes to access them on reasonable request. The data can be used for any type of analysis.
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.
Associate Professor Dr. Edmond Ng Siah Chye principal investigator
School of Healthy Ageing, Aesthetics & Regenerative Medicine, Faculty of Medicine and Health Sciences, UCSI University, Kuala Lumpur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intradermal exosome and 0.9 % NaCl in people with Alopecia Androgenica, run by COSMEDICIAN AP SDN BHD at 1 site in Malaysia.
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 4 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: finished, as of the sponsor's last update on 16 Apr 2025. 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 Malaysia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trichoscopic parameters: Total Hair Density (time frame: Baseline, 12, and 16 weeks post-treatment). The study lists 2 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 16 Apr 2025.