Exosome Treatment and Hair Growth (exosome)

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.

Study Overview

• Status: Completed
• Conditions: Alopecia Androgenica
• Intervention / Treatment: Other: 0.9 % NaCl; Other: intradermal exosome

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Subang Jaya, Selangor, Malaysia, 47500
      • Xeoul Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Norwood grade 2-3 androgenic alopecia among male Malaysians.
2. Aged between 20 and 50 years.
3. Demonstrated the ability to comprehend the study protocol and information provided by the investigators.
4. Participants willing to give informed consent.

Exclusion Criteria:

1. Pre-existing thyroid disorders, bleeding disorders, or diabetes.
2. Current use of any medical hair treatment.
3. Corticosteroid or immunosuppressive drug use.
4. Alopecia classified as Norwood scale 1, 4, 5, 6, 7, or cicatricial alopecia.
5. Smoking.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group (Group A), which received 0.9% sodium chloride	Other: 0.9 % NaCl; 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.
Experimental: Intervention group (Group B), received an Exosome-Containing Plant Extract Formulation	Other: intradermal exosome; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 12 weeks, and 16 weeks post-treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Assessments were carried out at baseline, 12 weeks, and 16 weeks post-treatment.

Collaborators and Investigators

• Sponsor: COSMEDICIAN AP SDN BHD
• Investigators: Principal Investigator: Associate Professor Dr. Edmond Ng Siah Chye, School of Healthy Ageing, Aesthetics & Regenerative Medicine, Faculty of Medicine and Health Sciences, UCSI University, Kuala Lumpur

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): April 5, 2023
• Study Completion (Actual): June 28, 2023

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Alopecia
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Alopecia Areata; Alopecia
• Other Study ID Numbers: UCSI-IEC-2022-FMHS-062.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No