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临床试验/CTRI/2022/08/044766
CTRI/2022/08/044766已完成3 期

A Prospective, Open-Label, Single Arm Study To Evaluate The Safety And Efficacy Of Bakutrol Face Cream For Its Anti-Acne Effect In Otherwise Healthy Male Or Female Volunteers

Viridis Bioharma Pvt Ltd0 个研究点目标入组 50 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Male and female patients aged 18 to 35 years
  • 2.Diagnosis of moderate facial acne vulgaris
  • 3.Phototype I II III or IV according to Fitzpatrick classification
  • 4.Facial inflammatory lesion count grater than 20 and
  • 5.Non inflammatory lesions count of at least 20-100
  • 6.Investigators Global Assessment score 3

排除标准

  • 1.Patients with 2 nodulocystic lesions, prior topical acne treatment or systemic anti-inflammatory agents in past 14 days.
  • 2.Patients on systemic corticosteroids, antibacterial, immunosuppressant drugs or abradant facial procedures in the past 30 days
  • 3.Patients with other concurrent facial skin disease and patients who are photosensitive or who are likely to engage in activities that involve excessive or prolonged exposure to sunlight.
  • 4.Patients with drug induced acne
  • 5.Patients with menopausal disorders
  • 6.Has a history of significant reactions to topical acne treatments, or a known allergy or hypersensitivity to any listed ingredients
  • 7.Use of oral retinoid within 6 months of Baseline visit.

研究者

发起方
Viridis Bioharma Pvt Ltd

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