About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Intervention Name：Test shampoo + basic shampoo for scalp care
Other intervention
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 shampoo
Other intervention
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.

Treatment groups

120 Participants

are divided into 3 treatment groups

Group A: Test Shampoo Group (SD)Experimental treatment 1 intervention

Group B: Basic Control Group (SD)Active comparator 1 intervention

Group C: Non-SD Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

2

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.

3

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

4

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

Secondary outcomes

1

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.

2

Product Usage Experience Feedback Questionnaire

Study participants shall complete the questionnaire on product usage experience and feedback.

Time frame

9 months after enrollment

3

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.

4

Wound Healing Assessment

Physicians assess the postoperative wound healing of study participants and keep records.

Time frame

7 days and 28 days after enrollment

Other outcomes

1

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

2

Tape stripping sampling

Time frame

14 days before enrollment, the day of enrollment and 28 days after enrollment

3

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

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

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