A Randomized, Assessor-Blinded, Intraindividual Study on the Efficacy of Fractional Carbon Dioxide Laser Versus Long-Pulsed 1064 nm Nd:YAG Laser in the Treatment of Keratosis Pilaris
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Assessment of Clinical Improvement or Worsening
研究概览
简要总结
This study compares the efficacy of fractional carbon dioxide laser versus long-pulsed 1064 nm Nd:YAG laser in the treatment of keratosis pilaris.
详细描述
The main study objective is to compare the efficacy, safety, and tolerability of fractional carbon dioxide versus long-pulsed 1064 nm Nd:YAG laser in the treatment of keratosis pilaris. This is a split-body trial involving three laser sessions delivered every four weeks, followed by one follow-up visit. Improvement is measured using clinical scores based on global assessment, the number of hyperkeratotic papules, erythema, and pigmentation. Dermoscopic assessment is focused on perifollicular erythema, coiled hair, and follicular hyperkeratosis. Patient satisfaction, adverse events, and procedural pain are evaluated.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 13 years old and above
- •Fitzpatrick skin types III or IV
- •Keratosis pilaris symmetrically affecting both upper outer arms
排除标准
- •Other variants and subtypes of keratosis pilaris: atrophoderma vermiculatum, erythromelanosis follicularis faciei et colli, folliculitis spinulosa decalvans, keratosis follicular spinulosa decalvans, keratosis pilaris atrophicans, keratosis pilaris atrophicans faciei, and keratosis pilaris rubra
- •Received any laser treatment, systemic retinoids, or dermabrasion for KP or for other indications (e.g. acne) within the past 6 months
- •Received topical treatment (including emollients, keratolytic agents, retinoids, or corticosteroids) for KP within the past month
- •Underwent hair removal by waxing, threading, or plucking in the areas to be treated within the past month
- •History of keloids or hypertrophic scars
- •Presence of other skin diseases in the area to be treated
- •History of autoimmune or photosensitive diseases
- •Intake of topical or oral photosensitizing medications
- •Pregnant or lactating
结局指标
主要结局
Assessment of Clinical Improvement or Worsening
时间窗: 4 months
Clinical photos were taken at baseline and 4 weeks after the last laser session using a 48-megapixel camera (iPhone 15 Pro Max, Apple). Initial assessment of the photographs was performed by the primary investigator and reviewed and verified by a blinded-board certified dermatologist. The scoring system was adapted from the Physician's Global Assessment (PGA) scoring. Baseline clinical scores for follicular keratotic papules were graded as follows: grade 1, mild = 0-25%; grade 2, moderate = 26-50%; grade 3, severe = 51-75%; grade 4, very severe = 76-100%. Erythema and pigmentation were graded as none, faint, moderate, and intense (1 to 4). Clinical improvement or worsening was rated as follows: grade -4, severe worsening \>75%; grade -3, marked worsening 51-75%; grade -2, moderate worsening 26-50%; grade -1, slight worsening 0-25%; grade 0, no improvement; grade 1 mild improvement 0%-25%; grade 2, moderate improvement 26%-50%; grade 3, marked improvement 51-75%; grade 4, excellent impr
Dermoscopic Findings Improvement or Worsening
时间窗: 4 months
A dermoscope (Illuco IDS-1100) with polarized and non-polarized modes was used to assess the dermoscopic findings. Dermoscopic photographs were initially assessed by the primary investigator and reviewed and verified by a blinded board-certified dermatologist with a certification in dermoscopy. Dermoscopic scores (0 to 5) for a fixed area on each treatment area were calculated at baseline and at follow-up, with perifollicular erythema graded as none, faint, moderate, and brownish (0 to 3). Coiled hair and hyperkeratosis were marked as present (1) or absent (0). These numbers were totaled per treatment area and were expressed as mean scores.
次要结局
- Pain Score(4 months)
- Patient Satisfaction(4 months)
研究者
Maria Korina Abao Dakis
Dermatology Resident/Principal Investigator
Jose R. Reyes Memorial Medical Center