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
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
Rajat Gupta
Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh
