A Study on Scalp Health and Integrated Scalp Management Protocols for Hair Transplant Patients
8 de junho de 2026 atualizado por: 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.
- 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.
- 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.
- Exploratory Objective To collect baseline clinical, physiological, biological and scalp microecological data from non-SD recipients after hair transplantation for reference purposes.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
120
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Yanwen Jiang
- Número de telefone: 13501700841
- E-mail: jiangyanwen@china-norm.com
Locais de estudo
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Shanghai, China
- Recrutamento
- Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072, Shanghai,
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Contato:
- Yanwen Jiang
- Número de telefone: +86 13501700841
- E-mail: jiangyanwen@china-norm.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Healthy Chinese male subjects aged between 18 and 55 years old;
- Diagnosed with androgenetic alopecia, with alopecia grade from Grade II to Grade VI per Hamilton-Norwood classification;
- Scheduled to receive hair transplantation; scalp condition is confirmed suitable for trial participation by dermatologist assessment after hair graft surgery;
- With or without mild-to-moderate scalp seborrheic dermatitis (SD score ranging from 0 to 9);
- No anti-dandruff shampoo used within the latest 14 days prior to enrollment;
- No hair dyeing, perming or hair styling cosmetic treatments in the past 30 days;
- Able to comply with all scheduled study visits;
- Possess normal communication and comprehension capacity;
- Agree to regular follow-up visits and complete related questionnaires on time;
- Fully understand trial procedures, volunteer to join the study and provide written informed consent.
Exclusion Criteria:
- Suffering from severe scalp seborrheic dermatitis;
- Received oral or topical antifungal drugs, glucocorticoids or other therapeutic medicines for seborrheic dermatitis within the preceding 30 days;
- Complicated with other scalp diseases (such as psoriasis), or with obvious infection or unhealed wounds on the target treatment area;
- Known hypersensitivity to ingredients including selenium disulfide, salicylic acid and related components;
- History of autoimmune diseases or severe organic diseases involving heart, brain, lung, liver, kidney and other vital organs;
- Past medical history of psychiatric or psychological disorders;
- Refuse to sign the written informed consent form;
- Currently enrolled in another interventional clinical trial;
- Diagnosed with alopecia areata, pseudopelade, cicatricial alopecia or other scalp and hair disorders;
- Have taken part in any other clinical trial within the prior 3 months;
- Judged as inappropriate for trial participation based on investigator's clinical assessment.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Test Shampoo Group (SD)
SD subjects receiving test shampoo plus basic shampoo
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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. |
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Comparador Ativo: Basic Control Group (SD)
SD subjects receiving basic shampoo alone
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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.
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Comparador Ativo: Non-SD Control Group
Non-SD subjects receiving basic shampoo alone
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Scalp Seborrheic Dermatitis Assessment
Prazo: 14 days before enrollment, the day of enrollment, and 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment.
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Physicians assess scalp seborrheic dermatitis (SD) in study participants and record scores and grades.
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14 days before enrollment, the day of enrollment, and 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment.
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Alopecia Grade Assessment
Prazo: 14 days before enrollment, and 28 days, 3 months, 6 months, and 9 months after enrollment.
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Physicians assess the alopecia grade of study participants and record the corresponding scores and grades.
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14 days before enrollment, and 28 days, 3 months, 6 months, and 9 months after enrollment.
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Scalp sebum content measurement using Sebumeter
Prazo: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment
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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.
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14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment
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Scalp stratum corneum moisture content measurement using Dermalab
Prazo: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment
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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.
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14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment
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Transepidermal Water Loss (TEWL) measurement using Vapometer
Prazo: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
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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.
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14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Subjective Symptom Assessment Questionnaire (Not required for NSD population)
Prazo: 14 days before enrollment, the day of enrollment, and 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment.
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Study participants shall conduct self-assessment of their scalp symptoms.
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14 days before enrollment, the day of enrollment, and 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment.
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Product Usage Experience Feedback Questionnaire
Prazo: 9 months after enrollment
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Study participants shall complete the questionnaire on product usage experience and feedback.
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9 months after enrollment
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Product Use Compliance Questionnaire
Prazo: the day of enrollment, and 28 days, 3 months, 6 months, and 9 months after enrollment.
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Study participants shall complete a questionnaire on product use compliance.
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the day of enrollment, and 28 days, 3 months, 6 months, and 9 months after enrollment.
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Wound Healing Assessment
Prazo: 7 days and 28 days after enrollment
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Physicians assess the postoperative wound healing of study participants and keep records.
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7 days and 28 days after enrollment
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Product Efficacy and Satisfaction Questionnaire
Prazo: the day of enrollment, and 28 days, 3 months, 6 months, and 9 months after enrollment.
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Study participants shall complete a questionnaire on the efficacy of the test product and their satisfaction with it.
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the day of enrollment, and 28 days, 3 months, 6 months, and 9 months after enrollment.
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Quality of Life Questionnaire (Exempt for NSD participants)
Prazo: 14 days before enrollment, the day of enrollment, and 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment.
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Study participants shall complete a questionnaire regarding the impact of scalp and hair conditions on their quality of life.
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14 days before enrollment, the day of enrollment, and 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment.
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General Photography
Prazo: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
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Staff shall take photos of participants' hair from fixed angles (15°, 45° and 90°) using a Canon 200D DSLR camera.
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14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
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Dermoscopy imaging and image analysis
Prazo: Photography time points: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
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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.
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Photography time points: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Evaluation of Complications and Adverse Reactions
Prazo: 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
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Physicians assess whether study participants develop complications or adverse reactions after product use, and document the findings.
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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
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Tape stripping sampling
Prazo: 14 days before enrollment, the day of enrollment and 28 days after enrollment
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14 days before enrollment, the day of enrollment and 28 days after enrollment
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Scaling scraping collection
Prazo: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
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14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
21 de fevereiro de 2025
Conclusão Primária (Estimado)
30 de dezembro de 2027
Conclusão do estudo (Estimado)
30 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
8 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de junho de 2026
Primeira postagem (Real)
11 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- C24005074
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .