An interventional study of Intervention Name:Test shampoo + basic shampoo for scalp care and Basic scalp care shampoo in Hair Transplantation, Seborrheic Dermatitis and Scalp Care, sponsored by ChinaNorm. Recruiting at 1 site in China. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by ChinaNorm · Not applicable, Interventional, and Other
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.
58 studies on the registry are indexed under Dermatitis, Seborrheic; 7 are open to participants now.
This study's planned enrollment of 120 is above the median of 77 across 47 interventional studies indexed under Dermatitis, Seborrheic.
Browse Dermatitis, Seborrheic studies →ChinaNorm is the lead sponsor of 30 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SD subjects receiving test shampoo plus basic shampoo
Other: Intervention Name:Test shampoo + basic shampoo for scalp care
SD subjects receiving basic shampoo alone
Other: Basic scalp care shampoo
Non-SD subjects receiving basic shampoo alone
Other: Basic scalp care shampoo
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 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.
Scalp Seborrheic Dermatitis Assessment
Physicians assess scalp seborrheic dermatitis (SD) in study participants and record scores and grades.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
Subjective Symptom Assessment Questionnaire (Not required for NSD population)
Study participants shall conduct self-assessment of their scalp symptoms.
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
Study participants shall complete the questionnaire on product usage experience and feedback.
Time frame: 9 months after enrollment
Product Use Compliance Questionnaire
Study participants shall complete a questionnaire on product use compliance.
Time frame: 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.
Time frame: 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.
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)
Study participants shall complete a questionnaire regarding the impact of scalp and hair conditions on their quality of life.
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
Staff shall take photos of participants' hair from fixed angles (15°, 45° and 90°) using a Canon 200D DSLR camera.
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
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.
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
Evaluation of Complications and Adverse Reactions
Physicians assess whether study participants develop complications or adverse reactions after product use, and document the findings.
Time frame: 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
Time frame: 14 days before enrollment, the day of enrollment and 28 days after enrollment
Scaling scraping collection
Time frame: 14 days before enrollment, the day of enrollment, 7 days, 28 days, 3 months, 6 months and 9 months after enrollment
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Dec 2027, 34 months after the start.
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