A Randomized Controlled Paired Comparison of Photo-therapy With a Topical Retinoid Cream Pretreatment Versus PDT Alone for Actinic Keratoses
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Live blinded rater and blinded photo rater analysis of areas at week 0 and week 6 for erythema, edema, crusting, ulceration, palpability, need to cease/delay treatment, and overall response in reduction of number of actinic keratoses (AKs).
研究概览
简要总结
Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy for the treatment of actinic keratoses.
详细描述
Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy vs photodynamic therapy alone for the treatment of actinic keratoses.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-80 years old
- •Subjects with AK lesions who will receive PDT
- •Subjects with AK lesions in two areas other than face and scalp each with a surface area of 10cm2 or greater and at least 3 clinically diagnosed non-hypertrophic AK lesions in each
- •Subjects in good health
- •Subjects with willingness and the ability to understand and provide informed consent
排除标准
- •Subjects who are pregnant or lactating
- •Subjects with a history of cutaneous photosensitivity or porphyria, hypersensitivity to porphyrins, or photodermatosis
- •Subjects with use of photosensitizing drugs within 1 week of study start
- •Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry
- •Subjects who received previous treatment of target AKs within 4 weeks
- •Subjects who are unable to understand the protocol or give informed consent
研究组 & 干预措施
1
Topical retinoid and Light therapy with photosensitizing agent
干预措施: Topical retinoid and blue-light therapy with photosensitizing agent (Procedure)
2
Light therapy with photosensitizing agent
干预措施: Photodynamic Therapy (PDT) (Procedure)
结局指标
主要结局
Live blinded rater and blinded photo rater analysis of areas at week 0 and week 6 for erythema, edema, crusting, ulceration, palpability, need to cease/delay treatment, and overall response in reduction of number of actinic keratoses (AKs).
时间窗: 6 weeks
次要结局
- Subjects will assess pain, burning and itching on a scale of 0-3 at week 0, during retinoid treatment, during photo-therapy, one day after, and week 6. Also, principal investigator will evaluate adverse events at week 6.(6 weeks)
研究者
Murad Alam
Associate Professor of Dermatology
Northwestern University