Scalp Care Efficacy Evaluation for Premium Revitalizing Elixir

This is a prospective, randomized, double-blinded, and placebo-controlled study to investigate the effects of Premium Scalp Revitalizing Essence on changes in the skin texture of human scalp skin.

This study aims to enroll 60 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 12 individuals in each group. Group 1 uses Placebo (Base formula without caffeine and panthenol); Group 2 uses the Base formula (Control with 0.1% caffeine and panthenol); Group 3 uses Base + IGF-1 \& FGF-7; Group 4 uses Base + Centella asiatica extracellular vesicles + Ginger-derived extracellular vesicles; Group 5 uses Base + Centella asiatica extracellular vesicles + Ginger-derived extracellular vesicles + IGF-1 \& FGF-7. Before using the test product, all 60 participants undergo the first scalp skin texture test. After 14 days of using the test product, a second scalp skin texture test is conducted; after 28 days of use, a third test is performed; after 42 days of use, a fourth test is conducted; and after 56 days of use, a fifth test is carried out. The scalp skin texture tests include measurements of skin (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. On Day 56, the participants will be asked to fill out a self-assessment form and a hair specialist will also assess the hair and scalp condition at the end of the study.

• Placebo control (Other): Placebo control (base formula without caffeine and panthenol). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.
• Base formula only (Other): Base formula consisting of active ingredients 0.1% caffeine and panthenol. Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.
• Base formula plus IGF-1 and FGF-7 (Other): Base formula plus insulin growth factor 1 (IGF-1) and fibroblast growth factor-7 (FGF-7). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.
• Base formula plus Centella asiatica and ginger extracellular vesicles (Other): Base formula plus Centella asiatica and ginger extracellular vesicles. Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.
• Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7 (Other): Base formula plus Centella asiatica and ginger extracellular vesicles, insulin growth factor-1 (IGF-1) and fibroblast growth factor-7 (FGF-7). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.

Primary outcomes

• Sebum Content [Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)]: 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.
• Hair length [Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)]: Hair length (cm): Measured manually with ruler at standardized scalp sites (left, right, and vertex).
• Hair density [Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)]: 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).
• Hair thickness [Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)]: Hair thickness (micrometers): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).
• Hair loss [Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)]: 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.

Secondary outcomes

• Participant self-assessment [Day 56 (End of the study period)]: Participants will be asked to fill out an assessment form with score from 0 to 4 for each of the hair and scalp condition evaluated.
• Hair specialist assessment [Day 56 (End of the study)]: A hair specialist will assess the hair and scalp condition of the participant and assign a score from 0 to 4 for each of the evaluated items as well as assign a score of Global Aesthetic Improvement Scale (GAIS) from -1 to 3.

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy adults of any gender from the age of 18 to 60 years (inclusive).
* Having symptoms of alopecia, baldness, or self-identified with hair thinning.
* Absence of chronic diseases, major illnesses, or allergies.
* Major illnesses include 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

Exclusion Criteria:

* Currently taking any medication or using any scalp care products
* Pregnant or breastfeeding
* Chronic diseases, significant illnesses, or allergic constitutions
* Currently using scalp care products
* Students or employees affiliated with the principal investigator,
* Individuals with scalp wounds
* Participated in cosmetic product testing
* Undergone scalp aesthetic treatments within the past three months.