Clinical trial NCT06985121: Scalp Care Efficacy Evaluation for Premium Scalp Revitalizing Essence
Official title: Evaluation of the Scalp Skin Care Effects of Premium Scalp Revitalizing Essence、Premium Scalp Revitalizing Essence 2、Premium Scalp Revitalizing Essence 3
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scalp Health
Hair Condition
Hair Loss
Sebum Production
Hair and Scalp Health
Keywords: Scalp care
Hair loss
Skin texture
Sebum measurement
Scalp condition
Hair length
Hair density
Cosmetics
Product formulation
Growth factor
Centella asiatica
Extracellular vesicles
Lead sponsor: Hungkuang University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the efficacy of the Premium Scalp Revitalizing Essence on human scalp skin. A total of 60 healthy adults, aged 18 to 60, will be recruited and randomly assigned into five groups receiving different formulations. Participants will use the product once daily for 56 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.

Detailed description: This is a prospective, randomized, open-labeled study to investigate the effects of Premium Scalp Revitalizing Essence on changes in the skin texture of human scalp skin.

Sixty healthy adults aged from 18 to 60 will be recruited and randomly assigned into five groups, with 12 individuals in each group. Group 1 uses Negative Control; Group 2 uses the Base formula (including active ingredient Panthenol \[Vit. B5\]); Group 3 uses Base + IGF-1 \& FGF-7; Group 4 uses Base + Centella asiatica extracellular vesicles; Group 5 uses Base + Centella Asiatica Exosome + 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.

Eligibility criteria: Inclusion Criteria:

* Healthy adults of any gender from the age of 18 to 60 years (inclusive).
* Absence of chronic diseases, major illnesses, or allergies.
* Major illnesses include cancer, post-stroke disorders, paralysis, acute myocardial infarction, coro-nary 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

Primary outcomes:
measure: Sebum Content
timeFrame: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: Hungkuang University
Study officials:
References: