Hair TransplantationNCT07641686
A Study on Scalp Health and Integrated Scalp Management Protocols for Hair Transplant Patients
A study of Hair Transplantation and Seborrheic Dermatitis, run by ChinaNorm at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Transplantation, Seborrheic Dermatitis, Scalp Care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072, Shanghai,
Shanghai
Yanwen Jiang, +86 13501700841, jiangyanwen@china-norm.com
About this study
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.
- Conditions
- Hair Transplantation, Seborrheic Dermatitis, Scalp Care
- Being tested
- Intervention Name：Test shampoo + basic shampoo for scalp care, Basic scalp care shampoo
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Name：Test shampoo + basic shampoo for scalp careOther
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.
Basic scalp care shampooOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Test Shampoo Group (SD) | Experimental | SD subjects receiving test shampoo plus basic shampoo Receives: Other: Intervention Name：Test shampoo + basic shampoo for scalp care |
| Basic Control Group (SD) | Active comparator | SD subjects receiving basic shampoo alone Receives: Other: Basic scalp care shampoo |
| Non-SD Control Group | Active comparator | Non-SD subjects receiving basic shampoo alone Receives: Other: Basic scalp care shampoo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scalp Seborrheic Dermatitis Assessment
Physicians assess scalp seborrheic dermatitis (SD) in study participants and record scores and grades.
Measured: 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
Physicians assess the alopecia grade of study participants and record the corresponding scores and grades.
Measured: 14 days before enrollment, and 28 days, 3 months, 6 months, and 9 months after enrollment.
Scalp sebum content measurement using Sebumeter
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.
Measured: 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
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.
Measured: 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
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.
Measured: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
Secondary outcomes (8)
Subjective Symptom Assessment Questionnaire (Not required for NSD population)
Study participants shall conduct self-assessment of their scalp symptoms.
Measured: 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
Study participants shall complete the questionnaire on product usage experience and feedback.
Measured: 9 months after enrollment
Product Use Compliance Questionnaire
Study participants shall complete a questionnaire on product use compliance.
Measured: the day of enrollment, and 28 days, 3 months, 6 months, and 9 months after enrollment.
Wound Healing Assessment
Physicians assess the postoperative wound healing of study participants and keep records.
Measured: 7 days and 28 days after enrollment
Product Efficacy and Satisfaction Questionnaire
Study participants shall complete a questionnaire on the efficacy of the test product and their satisfaction with it.
Measured: the day of enrollment, and 28 days, 3 months, 6 months, and 9 months after enrollment.
Quality of Life Questionnaire (Exempt for NSD participants)
Study participants shall complete a questionnaire regarding the impact of scalp and hair conditions on their quality of life.
Measured: 14 days before enrollment, the day of enrollment, and 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment.
General Photography
Staff shall take photos of participants' hair from fixed angles (15°, 45° and 90°) using a Canon 200D DSLR camera.
Measured: 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
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.
Measured: Photography time points: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start21 Feb 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair TransplantationStudies of the same condition, open and under way.
- More trials run by ChinaNormThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChinaNorm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641686
- Sponsor's protocol ID
- C24005074
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Scalp Health and Integrated Scalp Management Protocols for Hair Transplant Patients
- ClinicalTrials.gov ID
- NCT07641686
- Acronym / sponsor ID
- C24005074
- Conditions
- Hair Transplantation, Seborrheic Dermatitis, Scalp Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ChinaNormIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Shampoo Group (SD) | Experimental | Other: Intervention Name：Test shampoo + basic shampoo for scalp careSD subjects receiving test shampoo plus basic shampoo |
| Basic Control Group (SD) | Active comparator | Other: Basic scalp care shampooSD subjects receiving basic shampoo alone |
| Non-SD Control Group | Active comparator | Other: Basic scalp care shampooNon-SD subjects receiving basic shampoo alone |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Name：Test shampoo + basic shampoo for scalp careThe 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. | Other | Test Shampoo Group (SD) |
| Basic scalp care shampooBasic 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. | Other | Basic Control Group (SD), Non-SD Control Group |
Primary outcome
Scalp Seborrheic Dermatitis Assessment
Time frame: 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.
Alopecia Grade Assessment
Time frame: 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.
Scalp sebum content measurement using Sebumeter
Time frame: 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.
Scalp stratum corneum moisture content measurement using Dermalab
Time frame: 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.
Transepidermal Water Loss (TEWL) measurement using Vapometer
Time frame: 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.
8 secondary outcomes
Subjective Symptom Assessment Questionnaire (Not required for NSD population)
Time frame: 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
Time frame: 9 months after enrollment
Product Use Compliance Questionnaire
Time frame: the day of enrollment, and 28 days, 3 months, 6 months, and 9 months after enrollment.
Wound Healing Assessment
Time frame: 7 days and 28 days after enrollment
Product Efficacy and Satisfaction Questionnaire
Time frame: the day of enrollment, and 28 days, 3 months, 6 months, and 9 months after enrollment.
Quality of Life Questionnaire (Exempt for NSD participants)
Time frame: 14 days before enrollment, the day of enrollment, and 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment.
General Photography
Time frame: 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
Time frame: Photography time points: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hair Transplantation and Seborrheic Dermatitis, run by ChinaNorm at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanwen Jiang (13501700841, jiangyanwen@china-norm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scalp Seborrheic Dermatitis Assessment (time frame: 14 days before enrollment, the day of enrollment, and 7 days, 28 days, 3 months, 6 months, and 9 months after enrollment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.