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A Study on Scalp Health and Integrated Scalp Management Protocols for Hair Transplant Patients

8. Juni 2026 aktualisiert von: ChinaNorm

A total of 120 Chinese male subjects aged 18-50 years who have undergone hair transplantation are planned to be enrolled in this study. Among them, 90 participants with mild-to-moderate scalp seborrheic dermatitis (hereinafter abbreviated as SD) will be stratified and randomly allocated into two groups based on a randomization table with stratification factors including SD severity grading, alopecia classification and age. Subjects in the test product group (hereinafter referred to as the holistic group) will use the test shampoo plus basic shampoo, while those in the basic control group will receive only basic shampoo. The remaining 30 non-SD subjects will constitute the non-SD control group and use basic shampoo alone.

  1. Primary Objective To compare pre- and post-treatment changes in clinical, physiological, biological and microecological parameters related to SD manifestations, scalp health and skin barrier repair (including transepidermal water loss, scalp hydration, scalp sebum content, etc.) between the holistic group receiving the investigational shampoo regimen and the basic control group via non-invasive instrumental measurement, clinical assessment, clinical photography and subject self-evaluation. The safety and efficacy of the test product in improving scalp condition and skin barrier function will be evaluated, and its potential underlying mechanisms will be explored.
  2. Secondary Objective To investigate the impacts of the test product versus the control shampoo on hair transplant-associated complications (e.g., folliculitis), wound healing, follicular shedding phase, graft survival rate and hair growth parameters among SD patients.
  3. Exploratory Objective To collect baseline clinical, physiological, biological and scalp microecological data from non-SD recipients after hair transplantation for reference purposes.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

120

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienkontakt

Studienorte

  • China
      • Shanghai, China
        • Rekrutierung
        • Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072, Shanghai,
        • Kontakt:

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

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Inclusion Criteria:

  1. Healthy Chinese male subjects aged between 18 and 55 years old;
  2. Diagnosed with androgenetic alopecia, with alopecia grade from Grade II to Grade VI per Hamilton-Norwood classification;
  3. Scheduled to receive hair transplantation; scalp condition is confirmed suitable for trial participation by dermatologist assessment after hair graft surgery;
  4. With or without mild-to-moderate scalp seborrheic dermatitis (SD score ranging from 0 to 9);
  5. No anti-dandruff shampoo used within the latest 14 days prior to enrollment;
  6. No hair dyeing, perming or hair styling cosmetic treatments in the past 30 days;
  7. Able to comply with all scheduled study visits;
  8. Possess normal communication and comprehension capacity;
  9. Agree to regular follow-up visits and complete related questionnaires on time;
  10. Fully understand trial procedures, volunteer to join the study and provide written informed consent.

Exclusion Criteria:

  1. Suffering from severe scalp seborrheic dermatitis;
  2. Received oral or topical antifungal drugs, glucocorticoids or other therapeutic medicines for seborrheic dermatitis within the preceding 30 days;
  3. Complicated with other scalp diseases (such as psoriasis), or with obvious infection or unhealed wounds on the target treatment area;
  4. Known hypersensitivity to ingredients including selenium disulfide, salicylic acid and related components;
  5. History of autoimmune diseases or severe organic diseases involving heart, brain, lung, liver, kidney and other vital organs;
  6. Past medical history of psychiatric or psychological disorders;
  7. Refuse to sign the written informed consent form;
  8. Currently enrolled in another interventional clinical trial;
  9. Diagnosed with alopecia areata, pseudopelade, cicatricial alopecia or other scalp and hair disorders;
  10. Have taken part in any other clinical trial within the prior 3 months;
  11. Judged as inappropriate for trial participation based on investigator's clinical assessment.

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Test Shampoo Group (SD)
SD subjects receiving test shampoo plus basic shampoo
Sonstiges: Intervention Name：Test shampoo + basic shampoo for scalp care

The whole intervention is split into three sequential research stages: the pretreatment stage, the first test stage and the long-term follow-up stage.

1.14 days before enrollment up to the day of enrollment: Test shampoo A is used 3 times every week. If participants habitually wash hair every day, they shall use test shampoo A for 3 fixed weekly washes, and use basic shampoo for all other remaining shampooing times.

2.From the 7th study day to the 28th study day: Test shampoo B is used 3 times every week. Daily shampooing users apply test shampoo B 3 times weekly, and basic shampoo for additional hair washing.

3.From the 28th study day to the 9th month of the trial: Test shampoo A is used once weekly plus basic shampoo twice weekly. For daily shampoo users, test shampoo A can be flexibly used 1 to 3 times per week, with basic shampoo used for leftover washing times.
Aktiver Komparator: Basic Control Group (SD)
SD subjects receiving basic shampoo alone
Sonstiges: Basic scalp care shampoo
Basic shampoo is adopted consistently during three research periods: pretreatment stage (14 days before enrollment to enrollment day), first test stage (7th study day to 28th study day), and follow-up stage (28th study day to the 9th trial month). The standard usage frequency is 3 times weekly; participants with daily hair-washing habit are permitted to use basic shampoo every single day.All participants must finish shampooing at home 12-36 hours prior to each study visit and keep the same pre-visit shampooing interval all through the trial.
Aktiver Komparator: Non-SD Control Group
Non-SD subjects receiving basic shampoo alone
Sonstiges: Basic scalp care shampoo
Basic shampoo is adopted consistently during three research periods: pretreatment stage (14 days before enrollment to enrollment day), first test stage (7th study day to 28th study day), and follow-up stage (28th study day to the 9th trial month). The standard usage frequency is 3 times weekly; participants with daily hair-washing habit are permitted to use basic shampoo every single day.All participants must finish shampooing at home 12-36 hours prior to each study visit and keep the same pre-visit shampooing interval all through the trial.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Scalp Seborrheic Dermatitis Assessment
Zeitfenster: 14 days before enrollment, the day of enrollment, and 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment.
Physicians assess scalp seborrheic dermatitis (SD) in study participants and record scores and grades.
14 days before enrollment, the day of enrollment, and 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment.
Alopecia Grade Assessment
Zeitfenster: 14 days before enrollment, and 28 days, 3 months, 6 months, and 9 months after enrollment.
Physicians assess the alopecia grade of study participants and record the corresponding scores and grades.
14 days before enrollment, and 28 days, 3 months, 6 months, and 9 months after enrollment.
Scalp sebum content measurement using Sebumeter
Zeitfenster: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment
The instrument operates based on the photometric principle: a special opaque tape with a thickness of 0.1 mm absorbs sebum on the human skin and becomes translucent, resulting in a change in its light transmittance. The more sebum the tape absorbs, the higher its light transmittance, allowing the skin sebum content to be measured. Two points are measured on both the donor site and the recipient site, with one measurement taken at each point.
14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment
Scalp stratum corneum moisture content measurement using Dermalab
Zeitfenster: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment
This instrument measures stratum corneum moisture content based on the principle of electrical conductivity. Its unique probe design with eight needle-shaped electrodes allows reliable measurements even on the hairy scalp.The higher the measured value, the greater the moisture content.The technician refers to the measurement point diagram and follows the randomization table to select either the left or right side of the participant's scalp at random. The scalp moisture content is measured at the central point of the selected half-scalp (either the central area of the left half or the right half). One point is measured at the donor site and one at the recipient site, with three measurements taken at each point.
14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment
Transepidermal Water Loss (TEWL) measurement using Vapometer
Zeitfenster: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
The measuring probe of this instrument is a sealed cylindrical chamber. When placed in contact with the scalp, the relative humidity (RH %) inside the chamber rises, based on which the transepidermal water loss (TEWL) is calculated. A lower TEWL value indicates better skin barrier function.Referring to the position diagram and measurement randomization table, the technician performs TEWL measurement at the central point on either the left or right half of the participant's scalp. One point is tested on the donor site and one on the recipient site, with three replicates taken at each point.
14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Subjective Symptom Assessment Questionnaire (Not required for NSD population)
Zeitfenster: 14 days before enrollment, the day of enrollment, and 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment.
Study participants shall conduct self-assessment of their scalp symptoms.
14 days before enrollment, the day of enrollment, and 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment.
Product Usage Experience Feedback Questionnaire
Zeitfenster: 9 months after enrollment
Study participants shall complete the questionnaire on product usage experience and feedback.
9 months after enrollment
Product Use Compliance Questionnaire
Zeitfenster: the day of enrollment, and 28 days, 3 months, 6 months, and 9 months after enrollment.
Study participants shall complete a questionnaire on product use compliance.
the day of enrollment, and 28 days, 3 months, 6 months, and 9 months after enrollment.
Wound Healing Assessment
Zeitfenster: 7 days and 28 days after enrollment
Physicians assess the postoperative wound healing of study participants and keep records.
7 days and 28 days after enrollment
Product Efficacy and Satisfaction Questionnaire
Zeitfenster: the day of enrollment, and 28 days, 3 months, 6 months, and 9 months after enrollment.
Study participants shall complete a questionnaire on the efficacy of the test product and their satisfaction with it.
the day of enrollment, and 28 days, 3 months, 6 months, and 9 months after enrollment.
Quality of Life Questionnaire (Exempt for NSD participants)
Zeitfenster: 14 days before enrollment, the day of enrollment, and 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment.
Study participants shall complete a questionnaire regarding the impact of scalp and hair conditions on their quality of life.
14 days before enrollment, the day of enrollment, and 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment.
General Photography
Zeitfenster: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
Staff shall take photos of participants' hair from fixed angles (15°, 45° and 90°) using a Canon 200D DSLR camera.
14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
Dermoscopy imaging and image analysis
Zeitfenster: Photography time points: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
On the day of 14 days before enrollment, staff mark 2 to 3 points in the intended hair transplant area via scalp micropigmentation (SMP). At each SMP-marked site, examinations are conducted with the Fotofinder trichoscope to analyze hair density and hair diameter.
Photography time points: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Evaluation of Complications and Adverse Reactions
Zeitfenster: the day of enrollment (used for adverse reaction evaluation), as well as 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment
Physicians assess whether study participants develop complications or adverse reactions after product use, and document the findings.
the day of enrollment (used for adverse reaction evaluation), as well as 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment
Tape stripping sampling
Zeitfenster: 14 days before enrollment, the day of enrollment and 28 days after enrollment
14 days before enrollment, the day of enrollment and 28 days after enrollment
Scaling scraping collection
Zeitfenster: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment

Mitarbeiter und Ermittler

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

Sponsor

ChinaNorm

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)

21. Februar 2025

Primärer Abschluss (Geschätzt)

30. Dezember 2027

Studienabschluss (Geschätzt)

30. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

8. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juni 2026

Zuerst gepostet (Tatsächlich)

11. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • C24005074

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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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