Clinical trial NCT06930326: Exosome Treatment and Hair Growth
Official title: A Prospective, Randomized, Triple-blind Comparative Study of Exosome and Exosomes-containing Formulation Versus Placebo in Treating Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alopecia Androgenica
Keywords: Alopecia
Lead sponsor: COSMEDICIAN AP SDN BHD
Sponsor class: INDUSTRY
First posted: 2025-04-16
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Trichoscopic parameters: Total Hair Density
timeFrame: Baseline, 12, and 16 weeks post-treatment
measure: Modified global photographic assessment score (MGPA)
timeFrame: Baseline, 12 weeks, and 16 weeks post-treatment.
Secondary outcomes:
measure: Hair Growth Satisfaction Scale (HGSS)
timeFrame: Baseline, and week 16
measure: Trichoscopic parameters: Number of Empty Follicles
timeFrame: The assessments were performed at baseline, 12, and 16 weeks post-treatment.
measure: Trichoscopic Parameter: Percentage of Follicles with Peripilar Sign
timeFrame: The assessments were performed at baseline, 12, and 16 weeks post-treatment.
measure: Trichoscopic Parameter: Presence of Honeycomb Pigment Pattern (HCPP)
timeFrame: Assessments were conducted at baseline, 12 weeks, and 16 weeks post-treatment.
measure: Trichoscopic Parameter: Presence of Fibrosis
timeFrame: Assessments were carried out at baseline, 12 weeks, and 16 weeks post-treatment.
Other outcomes:
Locations:
city: Subang Jaya
country: Malaysia
facility: Xeoul Clinic
state: Selangor
Study officials:
affiliation: School of Healthy Ageing, Aesthetics & Regenerative Medicine, Faculty of Medicine and Health Sciences, UCSI University, Kuala Lumpur
name: Associate Professor Dr. Edmond Ng Siah Chye
role: PRINCIPAL_INVESTIGATOR
References: