androgenetic alopecia accompanied by mild-to-moderate seborrheic scalp dermatitis
Conditions
Interventions
intervention Group:Test shampoo (Record No. Su G Cosmetics Filing 2024001416) + microneedling treatment
Control Group:Basic Shampoo (Formula No.: 1110702 J) + Microneedle Treatment
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.Healthy Chinese male or female participants, with a required gender ratio of male : female = 1 : 2; 2.Aged 18–50 years (inclusive), with a history of androgenetic alopecia (AGA) not exceeding 8 years; 3.Diagnosed with seborrheic scalp dermatitis (SSD) based on clinical evaluation, with an SSD score between 3 and 9 (0–15 scale), balanced across groups; 4.After the 2-week run-in period using the test product, SSD score = 2.5 (0–10) with at least one region having an adherent dandruff score >= 1.5, balanced across groups (participants must avoid shampooing within 48 hours prior to each visit); 7.Vertex hair length >= 3 cm and willingness to maintain at least this length throughout the study (post-haircut length must also remain >= 3 cm); 8.Preferably natural chestnut-brown, dark brown, or black hair, to avoid contrast issues; 9.Willingness to shave approximately a 1 cm² scalp area for assessment; 10.AGA involving the F or V zone according to BASP classification (F1e–F2 or V1–V2); 11.Participants had not used any anti-dandruff shampoos during the two weeks preceding their baseline visit. 12.Agreement to use only the study-provided shampoo(s), and to avoid other hair-care products, styling products may be used except on clinic visit days; 13.Agreement to avoid any treatments that may influence hair growth, hair diameter, or hair loss during the study, including oral/topical medications (e.g., finasteride, isotretinoin), physical therapies (e.g., low-level laser therapy, mesotherapy), and surgical procedures (e.g., hair transplantation); 14.No use of medications within 3 months before enrollment that could affect study outcomes, including systemic reproductive or anti-androgenic agents, hair-growth treatments (e.g., minoxidil), or other drugs considered by the investigator to potentially interfere with results (e.g., isotretinoin); 15.No hair dyeing, perming, or special hairstyling procedures within 1 month before enrollment; 16.Willingness to attend regular follow-up visits with good compliance; 17.Good communication and comprehension abilities; 18.Ability to understand study procedures and voluntarily sign written informed consent and photo-use authorization.
Exclusion criteria
Exclusion criteria: 1. pregnant women, breastfeeding women, or women who plan to become pregnant during the study period; 2. study participants with visible or abundant white or blonde hair in the study area; 3. study participants who intend to colour, bleach or perm their hair during the study period; 4. study participants with severe SSD (SSD score >= 10), excluding study participants with severe erythema or severe scaling (erythema or scaling >= 4); 5. study participants with M-zone involvement only according to the BASP typing score; 6. study participants who plan to change their washing habits and frequency of washing (shampoo, conditioner) during the study period; 7. study participants with a history of cosmetic allergy and/or sensitivity or atopy similar to the study product or any other cosmetic product; 8. allergy to ingredients such as selenium disulfide and salicylic acid; 9. study participants who have received topical or oral scalp treatments (anti-seborrheic dermatitis, anti-dandruff, anti-alopecia) within one month prior to the study; 10. acute resting hair loss (e.g., sudden massive hair loss due to postpartum, drug stimulation, hyperthermia, etc.) and scarring hair loss (e.g., irreversible hair loss due to destruction of hair follicle structure and formation of skin scarring due to trauma, infection, autoimmune disease, etc.) conditions or with inflammatory skin diseases of the scalp (e.g., psoriasis, eczema, pemphigus vulgaris) or psychological disorder; 11. study participants with acute illnesses, or with unstable or progressive chronic diseases (e.g., diabetes mellitus, hypertension), or abnormalities of thyroid function (with the exception of stable hypothyroidism) that may interfere with the evolution or morphology of the skin condition; 12. study participants with life-threatening endocrine diseases, tumours or other serious illnesses; 13. study participants who have undergone surgery under general anaesthesia within one month prior to the start of the study or who intend to undergo surgery under general anaesthesia during the study; 14. research participants who plan to be hospitalised during the study; 15. study participants who are in the habit of wearing wigs or who have had hair extensions, who have had hair transplants, or who plan to undergo such procedures during enrolment; 16. study participants who have been excessively exposed to sunlight (natural or artificial) within 1 month prior to the start of the study or during the study period: e.g., long-term outdoor workers who perform outdoor work for more than 6 hours in a day, or those who are in the habit of sunbathing/tanning, open-air swimming on a regular basis: more than 1 time per month, etc; 17. those who are not willing to sign the informed consent form; 18. Those who are participating in another interventional clinical study; 19. those who have participated in another clinical trial within the last 3 months; 20. those who have been deemed unsuitable for participation in a trial by clinical assessment. 21. study participants who have received microneedling within 3 months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Scalp Seborrheic Dermatitis (SSD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Dandruff Assessment;global Assessment; | — |
Countries
China
Contacts
Public ContactWenyu Wu
Huashan Hospital, Fudan University
Outcome results
None listed