Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

8. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

120

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Test Shampoo Group (SD)
SD subjects receiving test shampoo plus basic shampoo
Jiný: 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.
Aktivní komparátor: Basic Control Group (SD)
SD subjects receiving basic shampoo alone
Jiný: 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.
Aktivní komparátor: Non-SD Control Group
Non-SD subjects receiving basic shampoo alone
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Scalp Seborrheic Dermatitis Assessment
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Subjective Symptom Assessment Questionnaire (Not required for NSD population)
Časové okno: 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
Časové okno: 9 months after enrollment
Study participants shall complete the questionnaire on product usage experience and feedback.
9 months after enrollment
Product Use Compliance Questionnaire
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Evaluation of Complications and Adverse Reactions
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

ChinaNorm

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

21. února 2025

Primární dokončení (Odhadovaný)

30. prosince 2027

Dokončení studie (Odhadovaný)

30. prosince 2027

Termíny zápisu do studia

První předloženo

8. června 2026

První předloženo, které splnilo kritéria kontroly kvality

8. června 2026

První zveřejněno (Aktuální)

11. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • C24005074

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Seboroická dermatitida

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Iran

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit