Alopecia Androgenica
Conditions
Keywords
Alopecia
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.
Interventions
OTHERintradermal 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.
OTHER0.9 % 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.
Sponsors
COSMEDICIAN AP SDN BHD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trichoscopic parameters: Total Hair Density | 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. |
| Modified global photographic assessment score (MGPA) | 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
| Measure | Time frame | Description |
|---|---|---|
| Trichoscopic Parameter: Percentage of Follicles with Peripilar Sign | 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. |
| Hair Growth Satisfaction Scale (HGSS) | 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: 1. = Strongly Disagree 2. = Disagree 3. = Neutral 4. = Agree 5. = 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. |
| Trichoscopic Parameter: Presence of Fibrosis | 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. |
| Trichoscopic Parameter: Presence of Honeycomb Pigment Pattern (HCPP) | 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. |
| Trichoscopic parameters: Number of Empty Follicles | 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. |
Countries
Malaysia
Outcome results
None listed