Scalp care for hair transplant patients using a test shampoo plus basic shampoo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial enrolls 120 healthy Chinese men aged 18-50 who recently underwent hair transplantation. Ninety participants with mild-to-moderate seborrheic dermatitis will be stratified by severity, hair loss type, and age and randomized to receive either a test shampoo plus basic shampoo or basic shampoo alone. Thirty participants without seborrheic dermatitis will serve as a non-dermatitis control group using only basic shampoo. The study will compare changes in clinical and biological markers of scalp health, including measures of skin barrier function and scalp microecology, before and after treatment. The primary objective is to determine whether the test shampoo provides added benefits for SD manifestations and overall scalp health after hair transplantation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072, Shanghai,
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Yanwen Jiang
• Email: jiangyanwen@china-norm.com
• Phone: 13501700841

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.