跳至主要内容
临床试验/CTRI/2026/03/105999
CTRI/2026/03/105999招募中Phase 3 4

To Compare the Efficacy and Safety of Probiotics as an Add on Therapy Vs Topical Therapy alone in patients of Acne Vulgaris A Randomized Controlled Study

Rajat Gupta1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年4月15日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
发起方
入组人数
150
试验地点
1

研究概览

简要总结

The study aims to compare the efficacy and safety of probiotics as an add on therapy with standard topical treatment versus topical treatment alone in patients with acne vulgaris

Acne vulgaris is a common chronic inflammatory disorder of the pilosebaceous unit that significantly affects young adults and has a negative impact on quality of life

Conventional topical therapies are effective but are often associated with adverse effects and variable patient compliance

Recent evidence suggests that the gut skin axis and intestinal microbiota play an important role in acne pathogenesis which has led to growing interest in the use of probiotics as an therapeutic option

This is a prospective randomised open label parallel group controlled clinical study conducted in the Department of Pharmacology and Dermatology at Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh Uttar Pradesh India

Patients aged eighteen to thirty five years with newly diagnosed Grade one and Grade two acne vulgaris will enrolled after obtaining informed consent

A total of one hundred fifty patients will be randomly divided into two groups

Group A will receive standard topical therapy while Group B will receive standard topical therapy along with oral probiotics for twelve weeks

The primary outcome measure will be the change in acne severity assessed by the Global Acne Grading System

Secondary outcome include assessment of quality of life using the Dermatology Life Quality Index and measurement of serum testosterone levels and monitoring of adverse drug reactions

Patients will be followed up at a regular intervals during the study period

The results of this study may provide evidence for a safe and patient friendly adjunctive approach in the management of acne vulgaris

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • Age 18 to 35 years Newly Diagnosed cases with Grade One and Grade Two Acne vulgaris.

排除标准

  • Severe nodulocystic acne requiring systemic isotretinoin Grade 3 Acne vulgaris or Pustular acne requiring oral antibiotics Antibiotic or Probiotic Therapy within the last 4 weeks Severely immunocompromised patients Pregnancy or lactation Known allergy to study products.

研究者

发起方
Rajat Gupta
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Rajat Gupta

Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh

研究点 (1)

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