Comparative therapeutic efficacy of different dosage regimens of oral isotretinoin in acne vulgaris
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- To compare the percentage reduction in total acne lesion count at 12 weeks among the
研究概览
简要总结
This study aims to compare the therapeutic efficacy of different dosage regimens of oral
isotretinoin in acne vulgaris. A total of 45 patients who fulfil the inclusion criteria and do not
meet any of the exclusion criteria will be randomly allocated into three groups of 15 patients
each using a random table method and prescribed different regimens of isotretinoin as per
allocation to the study groups. In each group, grading and scoring of acne will be done as per
Indian Acne Alliance guidelines. Patient will undergo liver function test and lipid profile test at
the first visit and at week 8. Patients must follow advised precautions including dual methods of
contraception for female patients of reproductive age group. UPT to be done twice at the start of
treatment and monthly thereafter till one month post completion of therapy in case of sexually
active female patients. Patients will receive treatment for 12 weeks. Follow up will be done at
four weekly intervals for which patients have to come to GMCH, Chandigarh. Assessment
including those of side effects will be done at each visit. Response to the therapy shall be
calculated on the basis of reduction in the total acne lesion count. Photographic records will be
taken for comparison at each visit.
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
- 16.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •All consecutive patients of acne vulgaris (Grade 2 and above) involving the face who have not received any treatment in the past four weeks.
排除标准
- •Pregnant females / females planning pregnancy within the next 9 months / breastfeedingfemales.
- •Immunosuppressed individuals.
- •Known hypersensitivity to synthetic / natural vitamin A.
- •Any systemic illness lasting more than three weeks.
- •Deranged liver function tests / lipid profile.
- •Reproductive age group females not willing to practice methods of contraception as advised.
结局指标
主要结局
To compare the percentage reduction in total acne lesion count at 12 weeks among the
时间窗: 0,4,8,12 weeks
three treatment groups.
时间窗: 0,4,8,12 weeks
次要结局
- To compare the adverse effects associated with each dosage regimen of oral(isotretinoin.)
研究者
Dr Priya Dagar
Government Medical College and Hospital