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Scalp Care Efficacy Evaluation for Premium Revitalizing Elixir

H

Hungkuang University

Status

Active, not recruiting

Conditions

Hair Thinning
Hair Loss
Scalp Health
Sebum Production
Hair Condition
Hair Health
Alopecia

Treatments

Other: Placebo control
Other: Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7
Other: Base formula plus Centella asiatica and ginger extracellular vesicles
Other: Base formula plus IGF-1 and FGF-7
Other: Base formula only

Study type

Interventional

Funder types

Other

Identifiers

NCT07271212
25-090-A

Details and patient eligibility

About

The study aims to evaluate the efficacy of the Premium Revitalizing Elixir on human scalp skin. A total of 60 healthy adults, aged 18 to 60 with alopecia, baldness, or self-identified with symptoms of hair thinning 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. A self-assessment and assessment by a hair specialist on hair and scalp condition will also be provided at the end of the study (Day 56).

Full description

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.

Enrollment

60 patients

Sex

All

Ages

18 to 60 years old

Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 5 patient groups, including a placebo group

Group 1: Placebo control
Placebo Comparator group
Description:
Base formula without caffeine and panthenol
Treatment:
Other: Placebo control
Group 2: Base formula only
Experimental group
Description:
Base formula consisting of active ingredients 0.1% caffeine and panthenol (vitamin B5).
Treatment:
Other: Base formula only
Group 3: Base formula plus IGF-1 & FGF-7.
Experimental group
Description:
Base formula plus insulin growth factor 1 (IGF-1) and fibroblast growth factor-7 (FGF-7)
Treatment:
Other: Base formula plus IGF-1 and FGF-7
Group 4: Base formula plus Centella asiatica and ginger extracellular vesicles
Experimental group
Description:
Base formula plus Centella asiatica and ginger (Zingiber officinale) extracellular vesicles
Treatment:
Other: Base formula plus Centella asiatica and ginger extracellular vesicles
Group 5: Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7.
Experimental group
Description:
Base formula plus Centella asiatica and ginger (Zingiber officinale) extracellular vesicles, insulin growth factor-1 (IGF-1) and fibroblast growth factor-7 (FGF-7).
Treatment:
Other: Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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