Exosome Treatment and Hair Growth

NCT ID: NCT06930326

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-06-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

0.9 % NaCl

Intervention Type: 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

Group Type: EXPERIMENTAL

intradermal exosome

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

COSMEDICIAN AP SDN BHD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Associate Professor Dr. Edmond Ng Siah Chye

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Xeoul Clinic

Subang Jaya, Selangor, Malaysia

Countries

Malaysia

Other Identifiers

UCSI-IEC-2022-FMHS-062.

Identifier Type: -

Identifier Source: org_study_id