Scalp Care Efficacy Evaluation for Premium Revitalizing Elixir

November 27, 2025 updated by: Tsong-Min Chang, Hungkuang University

Evaluation of the Scalp Skin Care Effects of Premium Revitalizing Elixir

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 433304
        • Hungkuang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
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.
Placebo Comparator: Group 1: Placebo control
Base formula without caffeine and panthenol
Other: 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.
Experimental: Group 2: Base formula only
Base formula consisting of active ingredients 0.1% caffeine and panthenol (vitamin B5).
Other: Base formula only
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.
Experimental: Group 4: Base formula plus Centella asiatica and ginger extracellular vesicles
Base formula plus Centella asiatica and ginger (Zingiber officinale) extracellular vesicles
Other: Base formula plus Centella asiatica and ginger extracellular vesicles
Base formula plus Centella asiatica and ginger extracellular vesicles. Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.
Experimental: Group 5: Base formula plus Centella asiatica and ginger 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hair loss
Time Frame: 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.
Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)
Sebum Content
Time Frame: 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.
Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
Hair length
Time Frame: 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).
Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
Hair density
Time Frame: 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).
Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)
Hair thickness
Time Frame: 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).
Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant self-assessment
Time Frame: 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.
Day 56 (End of the study period)
Hair specialist assessment
Time Frame: 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.
Day 56 (End of the study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hungkuang University

Collaborators

Schweitzer Biotech Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Estimated)

December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-090-A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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