Exosome Treatment and Hair Growth

NCT06930326 | Completed DMC

• 1 other identifier: UCSI-IEC-2022-FMHS-062.
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Alopecia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Hair Growth Satisfaction Scale (HGSS)

  Baseline, and week 16

• Trichoscopic parameters: Number of Empty Follicles

  The assessments were performed at baseline, 12, and 16 weeks post-treatment.

• Trichoscopic Parameter: Percentage of Follicles with Peripilar Sign

  The assessments were performed at baseline, 12, and 16 weeks post-treatment.

• Trichoscopic Parameter: Presence of Honeycomb Pigment Pattern (HCPP)

  Assessments were conducted at baseline, 12 weeks, and 16 weeks post-treatment.

• Trichoscopic Parameter: Presence of Fibrosis

  Assessments were carried out at baseline, 12 weeks, and 16 weeks post-treatment.

Study Arms (2)

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

Interventions

intradermal exosome OTHER

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.

Intervention group (Group B), received an Exosome-Containing Plant Extract Formulation

0.9 % NaCl OTHER

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.

Control group (Group A), which received 0.9% sodium chloride

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Norwood grade 2-3 androgenic alopecia among male Malaysians.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• COSMEDICIAN AP SDN BHD: lead

Study Sites (1)

Xeoul Clinic

Subang Jaya, Selangor, 47500, Malaysia

Location

MeSH Terms

Conditions

Alopecia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Associate Professor Dr. Edmond Ng Siah Chye

  School of Healthy Ageing, Aesthetics & Regenerative Medicine, Faculty of Medicine and Health Sciences, UCSI University, Kuala Lumpur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 16, 2025
• Study Start: November 1, 2022
• Primary Completion: April 5, 2023
• Study Completion: June 28, 2023
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

MY (1)