Scalp Care Efficacy Evaluation for Premium Scalp Revitalizing Essence

NCT ID: NCT06985121

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-08

Study Completion Date

2025-07-31

Brief Summary

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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

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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.

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 Placebo (Base formula without caffeine and panthenol); Group 2 uses the Base formula (Control with caffeine and panthenol); 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.

Conditions

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Scalp Health Hair Condition Hair Loss Sebum Production Hair and Scalp Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group 1: Placebo control

Base formula without caffeine and panthenol

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type OTHER

Placebo control (base formula without caffeine and panthenol). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.

Group 2: Base formula only

Base formula consisting of active ingredients caffeine and panthenol (vitamin B5).

Group Type EXPERIMENTAL

Base formula only

Intervention Type OTHER

Base formula consisting of active ingredients caffeine and panthenol. Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.

Group 3: Base formula plus IGF-1 & FGF-7.

Base formula plus insulin growth factor 1 (IGF-1) and fibroblast growth factor-7 (FGF-7)

Group Type EXPERIMENTAL

Base formula plus IGF-1 and FGF-7

Intervention Type 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 extracellular vesicles

Base formula plus Centella asiatica extracellular vesicles

Group Type EXPERIMENTAL

Base formula plus Centella asiatica extracellular vesicles

Intervention Type OTHER

Base formula plus Centella asiatica extracellular vesicles. Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.

Group 5: Base formula plus Centella asiatica extracellular vesicles, IGF-1 & FGF-7.

Base formula plus Centella asiatica extracellular vesicles, insulin growth factor-1 (IGF-1) and fibroblast growth factor-7 (FGF-7).

Group Type EXPERIMENTAL

Base formula plus Centella asiatica extracellular vesicles, IGF-1 & FGF-7

Intervention Type OTHER

Base formula plus Centella asiatica 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.

Interventions

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Placebo control

Placebo control (base formula without caffeine and panthenol). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.

Intervention Type OTHER

Base formula only

Base formula consisting of active ingredients caffeine and panthenol. Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.

Intervention Type OTHER

Base formula plus IGF-1 and FGF-7

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.

Intervention Type OTHER

Base formula plus Centella asiatica extracellular vesicles

Base formula plus Centella asiatica extracellular vesicles. Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.

Intervention Type OTHER

Base formula plus Centella asiatica extracellular vesicles, IGF-1 & FGF-7

Base formula plus Centella asiatica 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hungkuang University

OTHER

Sponsor Role lead

Responsible Party

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Tsong-Min Chang

Vice President

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hungkuang University

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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25-016-A

Identifier Type: -

Identifier Source: org_study_id

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