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临床试验/NCT04156815
NCT04156815已完成不适用

Treatment of Acne Vulgaris Using 1,565 nm Non-ablative Fractional Laser in Combination With Isotretinoin and Pricking Blood Therapy

xjpfW1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年7月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Visia CR imaging system

研究概览

简要总结

BACKGROUND Isotretinoin remains one of the first line medications for moderate-to-severe acne vulgaris (AV) but its side effect is a major concern for Asian patients.

OBJECTIVE Investigators aimed to evaluate the efficacy and safety of the 1,565 nm non-ablative fractional laser (NAFL) in combination with isotretinoin and pricking blood therapy (PBT) for treatment of AV.

METHODS A retrospective analysis of 60 patients with moderate-to-severe AV was performed. Four groups (n=15) were evaluated: 1,565nm NAFL alone, oral isotretinoin alone, double therapy (NAFL + isotretinoin) and triple therapy (NAFL + isotretinoin + PBT).

详细描述

BACKGROUND Isotretinoin remains one of the first line medications for moderate-to-severe acne vulgaris (AV) but its side effect is a major concern for Asian patients.

OBJECTIVE Investigators aimed to evaluate the efficacy and safety of the 1,565 nm non-ablative fractional laser (NAFL) in combination with isotretinoin and pricking blood therapy (PBT) for treatment of AV.

METHODS A retrospective analysis of 60 patients with moderate-to-severe AV was performed. Four groups (n=15) were evaluated: 1,565nm NAFL alone, oral isotretinoin alone, double therapy (1,565 nm non-ablative fractional laser + isotretinoin) and triple therapy (1,565 nm non-ablative fractional laser+ isotretinoin + PBT).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ranged in age from twenty to forty years old
  • Clinically diagnosed as a facial acne patient
  • The patients meet the needs of the research program of this topic

排除标准

  • pregnancy
  • liver or kidney functional abnormality
  • skin ulceration with active bacteria
  • fungal or viral infection or skin cancer
  • coagulation disorders
  • patients on drugs of agents
  • systemic diseases such as cardiovascular disease
  • immunodeficiency disease
  • active psoriasis

研究组 & 干预措施

1,565nm NAFL only group

Active Comparator

Patients were first treated by the 1,565nm M22-ResurFx NAFL on inflammatory papules and boxcar atrophic scars using round or rectangle light spots with similar sizes of individual lesional papules or scars. The energy fluence was 60 mJ and spot density was 150 spots/cm2. A whole face pass treatment was followed using hexagon or rectangle light spots with fluences of 40-45 mJ, density of 200 spots/cm2 and no overlap on light spots. The end points of the treatment were appearance of localized erythema, edema and bruise on treated areas. A facial sheet mask (skin repair dressing, Panion & BF Biotech Inc, Zhuhai, China) was used to clean the face after laser treatment, and the face was cooled by air cooler for 10 minutes. The patients received three treatment sessions with a 6-week interval between each session.

干预措施: 1,565nm NAFL (Radiation)

Oral isotretinoin only group

Active Comparator

Subjects received oral isotretinoin (Xingyi Yan'an Pharmaceutical, Shanghai, China) (1mg/kg/d for the first 2-4 weeks and 0.5mg/kg/d for the next 12-14 weeks) for a total of 16 weeks. Serum triglycerides, cholesterol and levels of liver enzymes were monitored every month during oral isotretinoin medication.

干预措施: Oral isotretinoin (Drug)

Double therapy group

Active Comparator

The patients first received 2-4 weeks of oral isotretinoin medication (1mg/kg/d), followed by 1565nm M22-ResurFx NAFL treatment. Subjects were then given isotretinoin with a dosage of 0.5 mg/kg/d for the next 12-14 weeks. Laser treatment parameters and procedures were as same as in the group one above.

干预措施: 1,565nm NAFL (Radiation)

Double therapy group

Active Comparator

The patients first received 2-4 weeks of oral isotretinoin medication (1mg/kg/d), followed by 1565nm M22-ResurFx NAFL treatment. Subjects were then given isotretinoin with a dosage of 0.5 mg/kg/d for the next 12-14 weeks. Laser treatment parameters and procedures were as same as in the group one above.

干预措施: Oral isotretinoin (Drug)

Triple therapy group

Experimental

The patients received the same treatments as the subjects in group (3) with additional PBT. At the end point of each session of laser treatment, an acupuncture practitioner performed a PBT in the areas within 1.5 cm radius of the five facial acupoints (Yintang, Zhukong, Sun, Yingxiang, Cuanzhu) (Figure 1). These areas usually appeared intensive erythema. A facial sheet mask was used to clean the face after PBT, and the face was cooled by air cooler for 10 minutes.

干预措施: 1,565nm NAFL (Radiation)

Triple therapy group

Experimental

The patients received the same treatments as the subjects in group (3) with additional PBT. At the end point of each session of laser treatment, an acupuncture practitioner performed a PBT in the areas within 1.5 cm radius of the five facial acupoints (Yintang, Zhukong, Sun, Yingxiang, Cuanzhu) (Figure 1). These areas usually appeared intensive erythema. A facial sheet mask was used to clean the face after PBT, and the face was cooled by air cooler for 10 minutes.

干预措施: Oral isotretinoin (Drug)

Triple therapy group

Experimental

The patients received the same treatments as the subjects in group (3) with additional PBT. At the end point of each session of laser treatment, an acupuncture practitioner performed a PBT in the areas within 1.5 cm radius of the five facial acupoints (Yintang, Zhukong, Sun, Yingxiang, Cuanzhu) (Figure 1). These areas usually appeared intensive erythema. A facial sheet mask was used to clean the face after PBT, and the face was cooled by air cooler for 10 minutes.

干预措施: Pricking blood therapy (Other)

结局指标

主要结局

Visia CR imaging system

时间窗: change from week0 to week24

With fast capture times and lighting modes designed to enhance the visualization

Antera3D® system

时间窗: change from week0 to week24

The indexes of facial skin texture and other datas were quantitatively measured by the Antera3D® system before and after treatments.

次要结局

未报告次要终点

研究者

发起方
xjpfW
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

xjpfW

Head of Dermatology

Xijing Hospital

研究点 (1)

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