The Pulsed Dye Laser as an Adjuvant Treatment Modality in Acne Vulgaris - a Randomized Controlled Single Blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Investigator's Static Global Assessment
研究概览
简要总结
The results of pulsed dye laser (PDL) treatment of acne vulgaris published so far are controversial: Whereas Seaton et al. described a marked improvement of mild-to-moderate acne after low-fluence pulsed-dye laser therapy, Orringer et al. were unable to replicate said results in a similar, albeit not identical, study design. More recently published studies failed to resolve the controversy, varying in terms of treatment procedure(s) as well as results.
While published results are certainly promising enough to be followed up by independent research, they are insufficient to justify the abdication of methods with proven efficacy. Considering patient treatment ethics and the short 'window of opportunity' for scar prevention when active inflammatory lesions are present, the investigators planned the adjuvant application of the PDL in the present study, providing all patients with the well established and evidentially effective modality of a fixed-combination clindamycin 1%-benzoyl peroxide 5% hydrating gel (C/BPO). The goal of the study was the assessment of the efficacy and safety of a low-fluence PDL treatment in addition to C/BPO in patients with facial inflammatory acne.
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
- •Adolescents and adults with moderate inflammatory acne vulgaris (ISGA degrees 2-4)
- •Fitzpatrick skin type I-III
排除标准
- •Atopic dermatitis
- •Oral antibiotics during the last 4 weeks prior to enrolment
- •Oral isotretinoin during the last 52 weeks prior to enrolment
- •Oral contraceptives during the last 26 weeks prior to enrolment
- •Topical acne therapeutics during the last 4 weeks prior to enrolment
- •Diagnosis or anamnestic indication of a regional enteritis, Morbus Crohn or antibiotics-associated colitis
- •Laser surgery interventions within the treatment region during the last 12 weeks prior to enrolment
- •Coagulation anomalies or anticoagulant treatment
- •Photo-sensitizing medication (e. g., tetracycline, gold)
- •Pregnancy
研究组 & 干预措施
Clindamycin 1% + benzoyl peroxide 5% & pulsed dye laser
干预措施: Pulsed dye laser (Device)
Clindamycin 1% + benzoyl peroxide 5%
干预措施: Fixed combination of clindamycin 1% + benzoyl peroxide 5% (Drug)
结局指标
主要结局
Investigator's Static Global Assessment
时间窗: day 0, day 14, day 28
Lesions count
时间窗: day 0, day 28
次要结局
- Dermatology Life Quality Index(day 0, day 28)
- Documentation of side effects(day 28)
