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Microneedle Transdermal Delivery of Compound Betamethasone in Alopecia Areata - A Randomized Controlled Trial

Clinical study on the efficacy and safety of transdermal administration of combined microneedle betamethasone in the treatment of alopecia areata

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087495
Enrollment
Unknown
Registered
2024-07-29
Start date
2021-06-05
Completion date
Unknown
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia Areata

Interventions

Control group:The drug was administered intralesionally using a standard syringe. The treatment regimen consisted of 1 ml of compound betamethasone injection (1 ml/vial, containing 5 mg of betamethaso
Experimental group:The drug was administered using a hollow microneedle (PA-NDL9P34G1 9PIn Screw Multi Needle, manufactured by Derma Shine, South Korea). The microneedle length was set to 2.0 mm. Apar

Sponsors

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 53 Years

Inclusion criteria

Inclusion criteria: A. Age between 18 and 55 years. B. Diagnosis of alopecia areata (AA) based on clinical presentation and trichoscopy. C. Disease type classified as patchy alopecia areata. D. Disease severity classified as mild to moderate (Severity of Alopecia Tool score, i.e., SALT < 50). E. Negative hair pull test. F. Disease duration = 6 months.

Exclusion criteria

Exclusion criteria: A. Severe AA with a SALT score = 50, including alopecia totalis. B. Involvement of hair beyond the scalp, including eyebrows, eyelashes, beard, axillary hair, pubic hair, or other body hair, including alopecia universalis. C. Presence of other conditions that could cause alopecia-like hair loss, such as androgenetic alopecia, syphilitic alopecia, trichotillomania, telogen effluvium, hair loss secondary to thyroid or other endocrine diseases, or scarring alopecia. D. Receipt of other localized treatments for AA within 4 weeks prior to enrollment, such as plum-blossom needle, roller needle, phototherapy, laser treatment, cryotherapy, hair transplantation, topical hair growth promoters (e.g., minoxidil solution, platelet-rich plasma, bimatoprost), topical irritants (e.g., anthralin, tazarotene, capsaicin tincture), topical immunotherapy (e.g., DPCP, SADBE), topical corticosteroids, topical tacrolimus ointment, or intralesional injections of corticosteroids or immunosuppressants. E. Receipt of systemic treatments for AA within 12 weeks prior to enrollment, including oral or injectable medications such as statins, antihistamines, corticosteroids, JAK inhibitors, PDE4 inhibitors, biologics (e.g., abatacept, IFN-? monoclonal antibody), immunosuppressants (e.g., methotrexate, cyclosporine), or traditional Chinese medicine. F. Presence of other conditions that may affect efficacy or safety evaluations, such as other active inflammatory skin diseases, other scalp-involving diseases, or scalp trauma. G. Presence of serious uncontrolled hypertension, diabetes, cardiovascular diseases, cerebrovascular diseases, or other severe underlying conditions. H. Presence of other contraindications to corticosteroid use or history of allergies to corticosteroids. I. Pregnancy, breastfeeding, or planning to become pregnant in the near future. J. Any other conditions deemed unsuitable for study participation by the investigator.

Design outcomes

Primary

MeasureTime frame
Severity of Alopecia Tools (SALT) score;

Secondary

MeasureTime frame
Trichoscopy results;Scalp Photography;Pain visual analog scale score;Adverse reactions and safety indicators;

Countries

China

Contacts

Public ContactJiang Yiqun

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College

yiqunjiang2017@163.com+86 135 1251 2661

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026