(Alopecia Areata, AA)? (Alopecia Totalis, AT)? (Alopecia Universalis, AU)
Conditions
Interventions
Group 1:5% Minoxidil Foam combined with Microneedling therapy
Group 2:5% Minoxidil Foam
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
8 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. The subject or their legal guardian must provide a signed and dated Informed Consent Form (ICF). 2. Male or female subjects aged 8 to 60 years at the time of signing the Informed Consent Form. 3. Subjects diagnosed with Alopecia Areata (AA), Alopecia Totalis (AT), or Alopecia Universalis (AU) based on clinical examination and investigator judgment. 4. Subjects with a Severity of Alopecia Tool (SALT) score >=10 during the screening period. 5. Subjects who are willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Immune dysfunction, severe liver or kidney dysfunction, severe cardiovascular disease, malignant tumor, acute or chronic infection, or other conditions that may interfere with the evaluation of trial results. 2. Concurrent scalp conditions that may affect assessment, such as cicatricial alopecia, tinea capitis, or severe seborrheic/contact dermatitis. 3. Patient with alopecia areata (AA), alopecia totalis (AT), or alopecia universalis (AU) in an acute progressive phase. 4. Systemic use of antibiotics, corticosteroids, immunosuppressants, biologics, or JAK inhibitors within the past 8 weeks; or use of topical scalp corticosteroids or other hair growth–stimulating therapies within the past 4 weeks. 5. Positive urine pregnancy test during screening / planned pregnancy during the trial period / lactation. 6. Presence of mental illness or inability to cooperate with treatment. 7. Confirmed uncontrolled parasitic infection. 8. The investigator or sponsor considers that the subject has any uncontrolled, clinically significant laboratory abnormality that may affect the interpretation of study data or the subject's participation in the study. 9. Participation in another clinical study of an investigational drug within 3 months before the start of study drug treatment, or still within 5 half-lives (if known) of the previous investigational drug (whichever is longer). Subjects who have participated in an investigational device study within 3 months or are still in the follow-up period of such a study (whichever is longer) are also excluded from this study. 10. Need for treatment with prohibited concomitant medications, or receipt of prohibited concomitant medications within the specified time window before the first dose of study drug. 11. Study site personnel involved in this study and their family members, as well as study site staff under the direct supervision of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SALT50 response rate at 12 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Trichoscopy findings; | — |
Countries
China
Contacts
Public ContactWang Dan
The Third Xiangya Hospital Central South University
Outcome results
None listed