Pilot Study for the Use of Photodynamic Therapy in the Treatment of Seborrheic Dermatitis
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- severity of seborrheic dermatitis before and after ALA treatment as determined by Seborrhea Area and Severity Index Face (SASI-F)
研究概览
简要总结
The purpose of this study is:
- To determine the efficacy of photodynamic therapy (PDT) in the treatment of seborrheic dermatitis.
- To determine how PDT alters the skin microbiome in subjects with seborrheic dermatitis before and after treatment.
- To determine how PDT alters sebum secretion rates in subjects with seborrheic dermatitis before and after treatment.
The researchers hypothesize that PDT will be efficacious in the treatment of seborrheic dermatitis.
详细描述
This pilot project investigates the use of PDT may be useful in the treatment of seborrheic dermatitis based on the following: The Malassezia spp is capable of forming biofilms, 2) PDT has been shown to be effective against Malassezia spp PDT can break up bioflims of both bacterial and fungal origin and benzoyl peroxide, a prooxidant treatment similar to PDT, has been shown to be effective in the treatment of seborrheic dermatitis.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy subjects 18 years or older with seborrheic dermatitis of the face will be included.
排除标准
- •Subjects who are taking systemic corticosteroids (at doses of prednisone greater than or equal to 5 mg daily), antibiotics (PO, IM or IV) or using topical anti- fungals, steroids, antibiotics, permethrin, or calcineurin inhibitors within 2 weeks prior to the study will be excluded.
- •The exclusion criteria will also include the presence of other untreated inflammatory conditions (such as lupus, atopic dermatitis, or psoriasis) or untreated malignancies on the face (including skin cancers such as basal cell carcinoma, squamous cell carcinoma and melanoma).
- •Any subjects with known or suspected hypersensitivity to any constituent of the study medication or a history of photosensitivity due to conditions such as lupus erythematosus and porphyria will be excluded.
- •Subjects who have had photodynamic therapy (PDT) to the face for any reason within the past year will be excluded as well.
- •Adults unable to consent, individuals under the age of 18, pregnant or breastfeeding women and prisoners will be excluded from the study.
研究组 & 干预措施
Application of ALA
The treatment will consist of split-face comparisons of no application of aminolevulinic acid (ALA) vs ALA application to either half of the face. Prior to ALA application, the face will be swabbed for microbiome analysis. After the ALA application, the subjects will incubate with the ALA on their face per the standard PDT protocol used at UC Davis Dermatology clinic for facial PDT treatments. The side of the face being treated will remain the same during all treatments.
干预措施: aminolevulinic acid (ALA) (Drug)
No Application of ALA
For the placebo, Demo Levulan Kerastick, which contains no active ingredient and is enclosed in same cardboard sleeve and cap, will be applied to the other side of the face to mimic the surface of the ALA application stick. After the placebo application, the subjects will incubate with the placebo on their face per the standard PDT protocol used at UC Davis Dermatology clinic for facial PDT treatments. The side of the face being treated will remain the same during all treatments.
干预措施: Placebo (Drug)
结局指标
主要结局
severity of seborrheic dermatitis before and after ALA treatment as determined by Seborrhea Area and Severity Index Face (SASI-F)
时间窗: up to 3 months
次要结局
- microbiome analysis before and after ALA treatment(up to 3 months)
- facial sebum production rates before and after ALA treatment(up to 3 months)