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<p>Androgenetic alopecia (AGA) is among the most prevalent forms of hair loss encountered in clinical practice. While current therapeutic options exist, they are often limited by efficacy, safety, or cost considerations. This study was designed to assess the efficacy and safety of polyglutamate (PGA) delivered via microneedle (MN) administration in patients with AGA. This prospective, open-label, single-arm clinical trial enrolled 30 diagnosed patients. Participants underwent a 12-week treatment regimen consisting of PGA repair fluid administered via microneedling at two-week intervals (total 6 sessions). Efficacy endpoints included dermatoscopic assessments of hair parameters (hair density, hair shaft diameter, and vellus hair proportion), scalp symptom scores, Dermatology Life Quality Index (DLQI) evaluations, patient-reported satisfaction, and investigator-assessed visual improvement alongside efficacy rate calculations. After 12 weeks of treatment, the overall efficacy rate reached 70%. Significant improvements were observed in hair density, hair shaft diameter, and the percentage of vellus hair. Scalp symptoms (including folliculitis, greasiness, itching, and dandruff), as well as quality of life scores and patient satisfaction scores, were markedly improved. No serious adverse reactions were reported. The results demonstrate that microneedle-assisted delivery of PGA (MN-PGA) represents a promising therapeutic approach for androgenetic alopecia, showing substantial clinical efficacy with a favorable safety profile. These findings suggest MN-PGA therapy may provide a valuable addition to the current armamentarium of AGA treatments. <i>Clinical Trial Registration</i>: Chinese Clinical Trial Registry (ChiCTR2600117408).</p>

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Clinical efficacy of polyglutamate via microneedle delivery: a novel non-invasive therapy for androgenetic alopecia

  • 期刊论文

  • 发表日期：

    2026年2月6日

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  • Lina Jin,
  • Songling Yao,
  • Xiaoyan Chen,
  • Sha Li,
  • Lin Zhou,
  • Ying Feng,
  • Jia Wang,
  • Shuai Huang

摘要

Androgenetic alopecia (AGA) is among the most prevalent forms of hair loss encountered in clinical practice. While current therapeutic options exist, they are often limited by efficacy, safety, or cost considerations. This study was designed to assess the efficacy and safety of polyglutamate (PGA) delivered via microneedle (MN) administration in patients with AGA. This prospective, open-label, single-arm clinical trial enrolled 30 diagnosed patients. Participants underwent a 12-week treatment regimen consisting of PGA repair fluid administered via microneedling at two-week intervals (total 6 sessions). Efficacy endpoints included dermatoscopic assessments of hair parameters (hair density, hair shaft diameter, and vellus hair proportion), scalp symptom scores, Dermatology Life Quality Index (DLQI) evaluations, patient-reported satisfaction, and investigator-assessed visual improvement alongside efficacy rate calculations. After 12 weeks of treatment, the overall efficacy rate reached 70%. Significant improvements were observed in hair density, hair shaft diameter, and the percentage of vellus hair. Scalp symptoms (including folliculitis, greasiness, itching, and dandruff), as well as quality of life scores and patient satisfaction scores, were markedly improved. No serious adverse reactions were reported. The results demonstrate that microneedle-assisted delivery of PGA (MN-PGA) represents a promising therapeutic approach for androgenetic alopecia, showing substantial clinical efficacy with a favorable safety profile. These findings suggest MN-PGA therapy may provide a valuable addition to the current armamentarium of AGA treatments. Clinical Trial Registration: Chinese Clinical Trial Registry (ChiCTR2600117408).