An interventional study of Base formula only and Base formula plus Centella asiatica extracellular vesicles, IGF-1 & FGF-7 in Scalp Health, Alopecia and Hair Condition, sponsored by Hungkuang University. Active, not recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Hungkuang University · Not applicable, Interventional, and Treatment
The study aims to evaluate the efficacy of two formulations on human scalp skin against established standard treatment of 5% minoxidil and base formula (placebo). A total of 40 healthy adults, aged 18 to 60 with alopecia, baldness, or self-identified with symptoms of hair thinning will be recruited and randomly assigned into four groups (n=10 for each group) receiving different formulations. Participants will use the product twice daily (once in the morning and once in the evening) for 84 days, and their scalp conditions will be assessed through skin texture tests at multiple time points. Key parameters such as sebum content, overall hair loss, hair density, scalp condition, and hair length will be measured at an interval of two weeks for a total of seven times, including baseline measurements.
This is a prospective, randomized, double-blinded, and placebo-controlled study to investigate the effects of two formulations on human scalp skin against established standard of care of topical 5% minoxidil and placebo control (base formulat).
This study enrolls 40 healthy adults aged from 18 to 60 with alopecia, baldness, or self-identified with symptoms of hair thinning.
Inclusion criteria include healthy adults defined as individuals without chronic diseases, significant illnesses (including cancer, post-stroke disorders, paralysis, acute myocardial infarction, coronary artery bypass surgery, end-stage renal disease, and major organ transplant or hematopoietic stem cell transplant), or allergic constitutions, and who are not currently taking any medication or using any scalp care products.
Exclusion criteria include individuals who are pregnant or breastfeeding, as well as males or females with chronic diseases, significant illnesses, or allergic constitutions, currently using scalp care products, students or employees affiliated with the principal investigator, individuals with scalp wounds, those who have participated in cosmetic product testing, and those who have undergone scalp aesthetic treatments within the past three months.
The participants will be randomly assigned into five groups, with 10 individuals in each group. Group 1 uses the Base formula (including 0.1% caffeine and panthenol); Group 2 uses Base + Centella asiatica extracellular vesicles + IGF-1 \& FGF-7; Group 3 uses Base + Centella asiatica extracellular vesicles + Ginger-derived extracellular vesicles + IGF-1 \& FGF-7; Group 4 uses commericial topical 5% minoxidil. Before using the test product, all participants undergo the first scalp skin texture test. The participants will apply interventions twice daily, once in the morning and once in the evening after hair wash. Assessments will be taken for every 14 days (including baseline) for up to Day 84. The assessments consist of: (1) sebum content, (2) overall hair loss, (3) hair density, (4) scalp condition, (5) hair length, and other parameters. The Sebumeter® SM815 probe of the MPA580 device and the ScalpX Intelligent Scalp Diagnostic System will be used to measure the parameters of the study.
511 studies on the registry are indexed under Alopecia; 128 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 430 interventional studies indexed under Alopecia.
Browse Alopecia studies →Hungkuang University is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Base formula consisting of active ingredients 0.1% caffeine and panthenol (vitamin B5).
Other: Base formula only
Base formula plus Centella asiatica extracellular vesicles, insulin growth factor-1 (IGF-1) and fibroblast growth factor-7 (FGF-7)
Other: Base formula plus Centella asiatica extracellular vesicles, IGF-1 & FGF-7
Base formula plus Centella asiatica and ginger (Zingiber officinale) extracellular vesicles, insulin growth factor-1 (IGF-1) and fibroblast growth factor-7 (FGF-7)
Other: Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7
Commercial topical 5% minoxidil
Other: 5% Topical Minoxidil Solution
Base formula consisting of 0.1% caffeine and panthenol. Apply 1mL evenly to the scalp twice daily, once in the morning and once in the evening (after hair wash) for 84 consecutive days.
Base formula plus Centella asiatica extracellular vesicles, insulin growth factor-1 (IGF-1) and fibroblast growth factor-7 (FGF-7). Apply 1mL evenly to the scalp twice daily, once in the morning and once in the evening (after hair wash) for 84 consecutive days.
Base formula plus Centella asiatica extracellular vesicles, insulin growth factor-1 (IGF-1) and fibroblast growth factor-7 (FGF-7). Apply 1mL evenly to the scalp twice daily, once in the morning and once in the evening (after hair wash) for 84 consecutive days.
Commercial 5% topical minoxidil solution. Apply 1mL evenly to the scalp twice daily, once in the morning and once in the evening (after hair wash) for 84 consecutive days.
Sebum Content
Assess oil levels on the scalp at standardized scalp sites (left, right, and vertex). Measured with C+K Multi Probe Adaptor MPA580 system using the Sebumeter® SM815 probe based on the grease spot photometry method with the sebum measurement cassette tape.
Time frame: Assessment conducted every 14 days from Day 0 to Day 84 (including Day 0 as baseline)
Hair length
Hair length (in cm): Measured manually with ruler at standardized scalp sites (left, right, and vertex).
Time frame: Assessment conducted every 14 days from Day 0 to Day 84 (including Day 0 as baseline)
Hair density
Hair density (number of hairs/cm-square): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).
Time frame: Assessment conducted every 14 days from Day 0 to Day 84 (including Day 0 as baseline)
Hair thickness
Hair thickness (in micrometers): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).
Time frame: Assessment conducted every 14 days from Day 0 to Day 84 (including Day 0 as baseline)
Hair loss
Assessed by the standardized hair combing test by counting the number of hairs shed after the participants' hair was combed over a clean surface for 60 strokes.
Time frame: Assessment conducted every 14 days from Day 0 to Day 84 (including Day 0)
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Hungkuang University