Efficacy and safety of ultralow dose isotretinoin versus low dose isotretinoin for the management of moderate to severe acne vulgaris: a single blinded randomized controlled trial
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- to observe Ultra-low dose of isotretinoin is non-inferior to low dose isotretinoin on clearance of acne among the patients with moderate to severe acne vulgaris.
研究概览
简要总结
our study is a randomised 1:1, parallel group,controlled single center, 12 month trial to be conducted in the outpatient department of dermatology, jipmer. patient in group A will recieve 0.3mg/kg ultra low dose of oral isotretinoin and group B will receive 0.6mg/kg of oral isotretinoin. Follow up assessment will be done at 3rd, 6th, 12th month for any flares. Main efficacy for low dose isotretinoin will be measured at 3rd month and for ultra low dose at 6th month to keep the cumulative doses of isotretinoin comparable in both groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 14.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 14 years Patients with moderate to severe acne (GAGSscore greater than 19).
排除标准
- •Pregnant and lactating women Leucopenia with leucocyte count less than 4000 per microlitre Liver enzymes (ALT/AST) above the upper limit of reference range Moderate to severe cholesterol and triglycerides elevation Deranged renal function test Known case of Hepatitis B or hepatitis C.
- •Concomitant use of other hepatotoxic drugs Any preexisting liver disease Sexually active females of reproductive age group who are not willing to use contraception as required.
- •Patients on any other immunosuppressive, immunomodulatory drugs or on drugs that has significant interaction with isotretinoin Known case of psychiatric disease Known hypersensitivity reaction to isotretinoin.
结局指标
主要结局
to observe Ultra-low dose of isotretinoin is non-inferior to low dose isotretinoin on clearance of acne among the patients with moderate to severe acne vulgaris.
时间窗: at baseline,3rd month,6th month and at the end of 1st year
次要结局
- To compare the adverse effect profile among the patients with moderate to severe acne treated with ultra low dose and low dose isotretinoin.(at baseline,3rd month,6th month and at the end of 1st year)
研究者
Dr Teertha Thamminaina
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),Pondicherry