NCT06985121

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 20, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2025

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

August 26, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

May 20, 2025

Last Update Submit

August 20, 2025

Conditions

Keywords

Scalp careHair lossSkin textureSebum measurementScalp conditionHair lengthHair densityCosmeticsProduct formulationGrowth factorCentella asiaticaExtracellular vesicles

Outcome Measures

Primary Outcomes (5)

  • Sebum Content

    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.

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

  • Hair length

    Hair length (cm): 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)

  • Hair density

    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)

  • Hair thickness

    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)

  • Hair loss

    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)

Study Arms (5)

Group 1: Placebo control

PLACEBO COMPARATOR

Base formula without caffeine and panthenol

Other: Placebo control

Group 2: Base formula only

EXPERIMENTAL

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

Other: Base formula only

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

EXPERIMENTAL

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 Centella asiatica extracellular vesicles

EXPERIMENTAL

Base formula plus Centella asiatica extracellular vesicles

Other: Base formula plus Centella asiatica extracellular vesicles

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

EXPERIMENTAL

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

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

Interventions

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

Group 1: Placebo control

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 2: Base formula only

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.

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

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

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.

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

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Currently taking any medication or using any scalp care products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hungkuang University

Taichung, 433304, Taiwan

Location

MeSH Terms

Conditions

Alopecia

Interventions

Insulin-Like Growth Factor I

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SomatomedinsInsulin-Like PeptidesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsBlood ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President

Study Record Dates

First Submitted

May 20, 2025

First Posted

May 22, 2025

Study Start

April 8, 2025

Primary Completion

July 18, 2025

Study Completion

July 31, 2025

Last Updated

August 26, 2025

Record last verified: 2025-06

Locations