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QR678 Neo 生发因子制剂皮内给药的安全性和有效性评价:一项四期、开放标签、单臂、多民族临床研究。

Evaluation of the safety and effectiveness of intradermal administration of QR678 Neo hair growth factor formulation: A phase-IV, open-label, single-arm multi-ethnicity clinical trial.

机构信息

Consultants, Aayna Clinics, New Delhi & Ludhiana, India.

Renew Aesthetics and IV Hydration Bar, Couer d'Alene, ID, USA.

出版信息

J Cosmet Dermatol. 2022 Feb;21(2):580-589. doi: 10.1111/jocd.14715. Epub 2022 Jan 8.

Abstract

BACKGROUND

Intradermal administration of QR678 Neo hair re-growth factor formulation has already proven its effectiveness and safety in treating androgenetic alopecia and female pattern hair loss.

AIM

This study aims to evaluate effectiveness and safety of hair re-growth factor formulation at multiple centers for reduction of hair fall and regrowth of hair in androgenetic alopecia and female pattern hair loss.

MATERIALS AND METHODS

An open-label, prospective, and interventional study was carried out at multiple centers of different countries. A total of 2428 patients with androgenetic alopecia and female pattern hair loss within the age range of 18-65 years were included in the study. Hair pull test, global photographic assessment, videomicroscopic assessment tests were performed at the beginning, after fourth and eighth sessions, and self-assessment through questionnaire related to satisfaction and side effects was carried out at beginning and at after eight session.

RESULTS

Hair pull test was positive in only 12% of the patients after eight sessions. Beneficial results were noted in the global assessment score (mean-6) after fourth session and eighth session (mean-8). Huge improvement was noted in terminal hair count, vellus hair count, and hair density after eighth sessions. Also, with self-assessment score, a higher satisfaction score was noted. On long-term follow-up as well, no side effects were noted.

CONCLUSION

Intradermal administration of QR678 Neo is an innovative, efficacious, and safe technique for the treatment of androgenetic alopecia and female pattern hair loss.

摘要

背景

QR678 新型生发因子制剂的皮内给药已被证明在治疗雄激素性脱发和女性型脱发方面的有效性和安全性。

目的

本研究旨在评估生发因子制剂在多个中心治疗雄激素性脱发和女性型脱发的脱发减少和毛发再生的有效性和安全性。

材料和方法

在多个不同国家的中心进行了一项开放性、前瞻性和干预性研究。共纳入 2428 名年龄在 18-65 岁之间的雄激素性脱发和女性型脱发患者。在开始、第四次和第八次治疗后进行毛发牵拉试验、全球摄影评估、视频显微镜评估测试,并在开始和第八次治疗后通过与满意度和副作用相关的问卷进行自我评估。

结果

第八次治疗后,仅 12%的患者毛发牵拉试验阳性。第四次和第八次治疗后,全球评估评分(平均-6)有改善。第八次治疗后,终毛计数、毳毛计数和毛发密度有显著改善。此外,自我评估评分显示满意度较高。长期随访也未发现不良反应。

结论

QR678 新型生发因子制剂皮内给药是一种创新性、有效且安全的治疗雄激素性脱发和女性型脱发的方法。

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