Red Low Level LASER Versus Narrow Band Ultraviolet B in the Treatment of Facial Acne Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- formal counts of active acne lesions.
研究概览
简要总结
Forty-five participants with facial AV were assigned randomly to three groups of fifteen subjects each. Each group received various therapies. Group A (Study group A) had received both NBUB and akne-Mycin; Group B( study group B) had received Red LLLT and akne-Mycin and group C (Control group) received only akne-Mycin cream. All 45 participants are tested at the initial treatments, after 4 weeks and after 8 weeks by the acne count, the intensity scale and the photographic test.
详细描述
Forty-five patient (18 male and 27 female) were recruited on a referral basis from the department of dermatology at Kasr Al- aini Teaching Hospital. Firstly, an interview was held with each participant to determine gender, age, skin type, acne severity and medical prescriptions,Randomization was performed by selecting numbers from opaque envelopes containing numbers that were chosen by a random number generator, selection was done by an independent person.
Patients in group (A) received a program of NBUB, ( DIXWELL EMLY 98 -ABRP 64 ,made in France) wavelength 311 to 313nm , in addition to topical aknemycin medications. Each treatment lasts one to eight minutes. The treatments were given three times a week. for 8 weeks.Participants in-group (B) received a program of R-LLLT that was conducted through laser equipment InGaAs (630 nm, 10 mW, continuous) (RIKTA, Russia) with fluence 12 J/cm2, two sessions per week for 8 weeks .Patients in the three groups were asked to apply topical erythromycin cream 2% (Akne-Mycin- Egypt) two times per day on the entire face from the beginning to the end of the treatment period .Evaluation was based on formal counts of active lesions (papule and pustule).facial photographs using a digital camera (PANASONIC, Tokyo, Japan). and Five-point scale of investigators assessment that reflect lesion count improved percentage.
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages ranged from 18-35 years.
- •Skin type III and IV.
- •Mild to moderate facial acne.
排除标准
- •Treatment with oral retinoid within past 1 year.
- •Treatment with other acne treatment within past 3 months.
- •History of treatment with systemic and topical antibiotics for acne vulgaris within the last 1 month.
- •Treatment with oral isotretinoin within the last 6 months.
- •Participants received radiotherapy or chemotherapy.
- •Any history of photosensitivity.
- •Chemical peels during the previous 4 weeks.
- •Seizures,
- •Pregnancy
- •Use of oral contraceptives.
- •Breastfeeding .
研究组 & 干预措施
Experimental group 1
Patients in group (A) consisted of 15 participants, received a program of NBUB, DIXWELL EMLY 98 -ABRP 64 ,made in France (wavelength 311 to 313nm) , in addition to topical aknemycin medications (topical erythromycin cream 2% (Akne-Mycin- Egypt) two times per day on the entire face from the beginning to the end of the treatment period after 8 weeks).
干预措施: Narrow band ultraviolet B. (Device)
Experimental group 1
Patients in group (A) consisted of 15 participants, received a program of NBUB, DIXWELL EMLY 98 -ABRP 64 ,made in France (wavelength 311 to 313nm) , in addition to topical aknemycin medications (topical erythromycin cream 2% (Akne-Mycin- Egypt) two times per day on the entire face from the beginning to the end of the treatment period after 8 weeks).
干预措施: topical erythromycin cream 2% (Akne-Mycin- Egypt) (Drug)
Experimental group 2
Participants in-group (B) consisted of 15 participants, received a program of R-LLLT that was conducted through laser equipment InGaAs (630 nm, 10 mW, continuous) (RIKTA, Russia) with fluence 12 J/cm2, two sessions per week for 8 weeks Plus topical erythromycin cream 2% (Akne-Mycin- Egypt) two times per day on the entire face from the beginning to the end of the treatment period.
干预措施: Narrow band ultraviolet B. (Device)
Experimental group 2
Participants in-group (B) consisted of 15 participants, received a program of R-LLLT that was conducted through laser equipment InGaAs (630 nm, 10 mW, continuous) (RIKTA, Russia) with fluence 12 J/cm2, two sessions per week for 8 weeks Plus topical erythromycin cream 2% (Akne-Mycin- Egypt) two times per day on the entire face from the beginning to the end of the treatment period.
干预措施: topical erythromycin cream 2% (Akne-Mycin- Egypt) (Drug)
Control group
Patients in the group C, consisted of 15 participants, were asked to apply topical erythromycin cream 2% (Akne-Mycin- Egypt) two times per day on the entire face from the beginning to the end of the treatment period.
干预措施: topical erythromycin cream 2% (Akne-Mycin- Egypt) (Drug)
结局指标
主要结局
formal counts of active acne lesions.
时间窗: 8 weeks.
The lesion number was individually counted by lesion type at all three times of evaluation as the number of papules and pustules
次要结局
- facial photographic method.(8 weeks.)
研究者
Hadaya Mosaad
Principal investigator.
Cairo University