Exosome Treatment and Hair Growth (exosome)

COSMEDICIAN AP SDN BHD

Status: Completed

Conditions: Alopecia Androgenica

Treatments: Other: intradermal exosome; Other: 0.9 % NaCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT06930326

UCSI-IEC-2022-FMHS-062.

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

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

Placebo Comparator group

Treatment:

Other: 0.9 % NaCl

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

Experimental group

Treatment:

Other: intradermal exosome