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Completed

NCT Number: NCT06930326

Exosome Treatment and Hair Growth

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.

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Key information

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Xeoul Clinic

Subang Jaya, Selangor, 47500, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Trichoscopic parameters: Total Hair Density

    Time frame: Baseline, 12, and 16 weeks post-treatment

    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.

  2. Modified global photographic assessment score (MGPA)

    Time frame: Baseline, 12 weeks, and 16 weeks post-treatment.

    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.

Secondary outcomes

  1. Hair Growth Satisfaction Scale (HGSS)

    Time frame: Baseline, and week 16

    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.
  2. Trichoscopic parameters: Number of Empty Follicles

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

    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.

  3. Trichoscopic Parameter: Percentage of Follicles with Peripilar Sign

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

    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.

  4. Trichoscopic Parameter: Presence of Honeycomb Pigment Pattern (HCPP)

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

    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.

  5. Trichoscopic Parameter: Presence of Fibrosis

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

    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.

Sponsors and collaborators

Lead sponsor

COSMEDICIAN AP SDN BHD

Industry

Registry information

Official study title

A Prospective, Randomized, Triple-blind Comparative Study of Exosome and Exosomes-containing Formulation Versus Placebo in Treating Alopecia

Acronym: exosome

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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