Treatment of Keratosis Pilaris With 810 nm Diode Laser
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Difference in Disease Severity Scores
研究概览
简要总结
The investigators hope to establish whether or not the diode laser, a longer-wavelength laser, is effective in treating keratosis pilaris, and hopefully opening a door into the discussion and management of this skin condition. The primary outcome of interest is the difference in the overall blind rater severity scores of the treated versus the untreated sites. The secondary outcome of interest is the change in the patient's self-rated severity score of the treated site. To account for potential natural disease progression or regression, the investigators will also compare patient mean changes to the mean changes in severity scores of the untreated site.
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
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is age 18 to 65
- •Subject has diagnosis of keratosis pilaris involving both arms
- •Subject has Fitzpatrick Skin Type I - III
- •Subject is in good health
- •Subject has the willingness and ability to understand and provide informed consen
排除标准
- •Under 18 or over 65 years of age
- •Subjects with Fitzpatrick Skin Type greater than III
- •Subjects who have received any laser therapy to the armsin the past year
- •Subjects with concurrent diagnosis of another skin condition or malignancy
- •Subjects with tan or sunburn over the upper arms in the past month
- •Subjects with open, non-healing sores or infections at any skin site
- •Subjects who are unable to understand the protocol or give informed consent
- •Subjects who take oral photosensitizing medications or who apply topical photosensitizing medications to either arm
结局指标
主要结局
Difference in Disease Severity Scores
时间窗: 12 weeks
The primary outcome measure was the difference in disease severity total score, combining redness and roughness/bumpiness scales, between the treated site and the control site, as rated by the blinded dermatologists at 12 weeks post-initial visit. These scales were not validated, as no relevant validated scale was available. However, raters were trained and calibrated on the use of the scale, and prior to review of study images, were asked to rate archival skin images on the same 4-point qualitative subscales used in the study. Each scale ranged from 0 to 3, with 0 being none and 3 being severe. The total score summed the redness and roughness/bumpiness scale scores for a range of 0 (none/better outcome) to 6 (severe/worse outcome).
次要结局
- Patient Self-rated Severity(12 weeks)
研究者
Murad Alam
Associate Professor of Dermatology
Northwestern University