Randomised Controlled Trial of Two Different Cumulative Dosages of Roaccutane for Cystic Acne
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 主要终点
- Change in Total Acne Lesion Count During Isotretinoin Treatment
研究概览
简要总结
This randomized, single-blind, controlled trial was initiated in 2001 to compare two cumulative isotretinoin doses (120 mg/kg vs 150 mg/kg) in patients with moderate-to-severe nodulo-cystic acne. Participants were assigned to receive a cumulative dose of either 120 mg/kg or 150 mg/kg, administered according to body weight and clinical response.
The primary objectives were to evaluate changes in total acne lesion counts and global acne severity grade from baseline through mid-treatment and end of treatment. Secondary objectives included assessing acne recurrence within 12 months after treatment completion and evaluating changes in acne scarring on the face, chest, and back over follow-up.
A small post-hoc extension cohort included patients who had not achieved satisfactory improvement after reaching their assigned cumulative dose and continued isotretinoin beyond standard targets. These patients were analysed descriptively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female subjects, of any age and any race
- •Clinical diagnosis of nodulo-cystic acne as well as patients who have been unresponsive to standard acne vulgaris treatments
排除标准
- •Pregnant or lactating female patients
- •Female patients with polycystic ovarian syndrome, insulin resistance syndrome, previous use of Roaccutane, patients with congenital adrenal hyperplasia, patients with any internal malignancy (excluding skin cancer)
- •Females of reproductive potential who refuse to take the oral contraceptive pill to take Roaccutane; patients who in the investigator's opinion would be unlikely to be compliant
研究组 & 干预措施
Roaccutane 120 mg/kg Group
Participants in this arm received a cumulative dose of approximately 120 mg/kg of Roaccutane (isotretinoin) administered over the treatment period. Dosing was adjusted according to body weight and clinical response, following standard isotretinoin treatment protocols. The outcomes in this group were compared with those in the 150 mg/kg group to assess differences in efficacy, relapse rate, and adverse effects.
干预措施: isotretinoin (Roaccutane) (Drug)
Roaccutane 150 mg/kg Group
Participants in this arm received a cumulative dose of approximately 150 mg/kg of Roaccutane (isotretinoin) administered over the treatment period. Dosing was adjusted according to body weight and standard clinical guidelines for isotretinoin therapy. The outcomes for this group were compared with those of the 120 mg/kg group to evaluate differences in efficacy, relapse rates, and adverse effects.
干预措施: isotretinoin (Roaccutane) (Drug)
结局指标
主要结局
Change in Total Acne Lesion Count During Isotretinoin Treatment
时间窗: Baseline, Week 16, and end of treatment (defined as the visit at which the assigned cumulative dose of 120 mg/kg or 150 mg/kg was reached)
Change in the total number of acne lesions (whiteheads, blackheads, papules, pustules, nodules, and deep pustules) measured on the face, chest, and back from baseline to week 16, and to the cumulative doses of 120 mg/kg and 150 mg/kg isotretinoin (Roaccutane). Results will be reported as the mean number of lesions at each time point. Lower counts indicate better clinical response.
Change in Acne Severity Grade During Isotretinoin Treatment
时间窗: Baseline, Week 16, and end of treatment (defined as the visit at which the assigned cumulative dose of 120 mg/kg or 150 mg/kg was reached)
Change in acne severity grade, ranging from 1 (least severe) to 8 (most severe), according to the classification described in Dermatology 1999;198:278-283 (Karger). Assessments are performed at baseline, week 16, and at cumulative isotretinoin doses of 120 mg/kg and 150 mg/kg. Results will be reported as mean acne grade (1-8 scale); lower scores indicate better outcome.
次要结局
- Rate of Acne Relapse at 3 Months After End of Treatment(3 months after completion of isotretinoin treatment)
- Rate of Acne Relapse at 12 Months After End of Treatment(12 months after completion of isotretinoin treatment)
- Change in Acne Scarring Over Time(Baseline, end of treatment (defined as the visit at which the assigned cumulative dose of 120 mg/kg or 150 mg/kg was reached) and 12 months after completion of treatment)
研究者
Dedee Murrell
Professor, Director of Premier Specialists
Premier Specialists, Australia