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Effektivitätsbewertung der Kopfhautpflege für Premium Revitalisierungs-Elixier

9. November 2026 aktualisiert von: Tsong-Min Chang, Hungkuang University

Evaluierung der pflegenden Effekte auf die Kopfhaut durch das 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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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 (each growth factor at twice the concentration than that in Group 3). 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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Taiwan
      • Taichung, Taiwan, 433304
        • Hungkuang University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 60 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Group 1: Placebo control

Base formula without caffeine and panthenol
Sonstiges: 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).
Sonstiges: 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 3: Base formula plus IGF-1 & FGF-7.

Base formula plus insulin growth factor-1 (IGF-1, 250 ng/mL) and fibroblast growth factor-7 (FGF-7, 150 ng/mL)
Sonstiges: Base formula plus IGF-1 and FGF-7

Base formula plus insulin growth factor-1 (IGF-1, 250 ng/mL) and fibroblast growth factor-7 (FGF-7, 150 ng/mL). 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 (1E9 particles/mL)
Sonstiges: Base formula plus Centella asiatica and ginger extracellular vesicles

Base formula plus Centella asiatica and ginger extracellular vesicles (1E9 particles/mL). 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 (both 1E9 particles/mL), insulin growth factor-1 (IGF-1, 500 ng/mL) and fibroblast growth factor-7 (FGF-7, 300 ng/mL)
Sonstiges: Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7

Base formula plus Centella asiatica and ginger extracellular vesicles (both 1E9 particles/mL), insulin growth factor-1 (IGF-1, 500 ng/mL) and fibroblast growth factor-7 (FGF-7, 300 ng/mL). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sebum Content
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Hair loss
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Participant self-assessment
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hungkuang University

Mitarbeiter

Schweitzer Biotech Company

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. November 2025

Primärer Abschluss (Tatsächlich)

31. Mai 2026

Studienabschluss (Tatsächlich)

31. Mai 2026

Studienanmeldedaten

Zuerst eingereicht

27. November 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. November 2025

Zuerst gepostet (Tatsächlich)

9. Dezember 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 25-090-A

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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