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Completed

NCT Number: NCT06985121

Scalp Care Efficacy Evaluation for Premium Scalp Revitalizing Essence

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.

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Key information

Conditions

Scalp Health Alopecia Hair Condition Hair Diseases Hair Loss Hair and Scalp Health Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sebum Production Skin Diseases Skin and Connective Tissue Diseases

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hungkuang University

Taichung, 433304, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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 extracellular vesicles

Other

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

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

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.

Primary outcomes

  1. Sebum Content

    Time frame: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)

    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. The change in light transmission corresponds to the amount of sebum on the tape and is displayed on a scale from 0 to 350 units.

  2. Hair length

    Time frame: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)

    Hair length (cm): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).

  3. Hair density

    Time frame: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)

    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).

  4. Hair thickness

    Time frame: Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)

    Hair thickness (micrometers): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).

  5. 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.

Sponsors and collaborators

Lead sponsor

Hungkuang University

Other

Registry information

Official study title

Evaluation of the Scalp Skin Care Effects of Premium Scalp Revitalizing Essence、Premium Scalp Revitalizing Essence 2、Premium Scalp Revitalizing Essence 3

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 22, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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