Combination Topical Cysteamine and Fractional 1927nm Low-Powered Diode Laser
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UnionDerm
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary objective of our study is to determine the efficacy of combined topical cysteamine cream with a 1927 diode non-ablative laser (Clear + Brilliant Permea®; Solta Medical, Inc.), compared to topical cysteamine alone in the treatment of melasma.
研究概览
简要总结
The primary objective of our study is to determine the efficacy of combined topical cysteamine cream with a 1927 diode non-ablative laser (Clear + Brilliant Permea®; Solta Medical, Inc.), compared to topical cysteamine (Cyspera) alone in the treatment of melasma.
The main questions it aims to answer are
- If melasma treatment with topical cysteamine cream is more effective when used with the Clear & Brilliant® Permea laser
- The safety & efficacy of melasma treatment in various skin types using the Clear & Brilliantt® Permea laser in combination with topical cysteamine.
Participants will
- Come into our office for an initial screening appointment to determine if participant is eligible for the study
- Come in for 3 laser treatments, 4 weeks apart, on 1 side of the face
- Use the study provided Cyspera topical cream every day on the entire face for the 12 weeks on the study.
Researchers will compare the side of the participants face not treated with laser to the side of the face treated with laser. The participants will be using Cyspera on both sides of their face.
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)
盲法说明
Photographic assessment by two blinded dermatologists will measure changes will assess improvement in melasma by mMASI score. In addition, an investigator quartile improvement score from baseline to week 12 (0 - 0%, no improvement; 76%-100% - very significant improvement) will be assessed.
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects of Skin Type I-VI females.
- •Subjects must be between 18 and 74 years of age, and must have visible melasma on the face.
- •Subjects must read, understand, and sign the Informed Consent.
- •Subjects must be willing and able to comply with all follow-up requirements.
排除标准
- •Subjects must not have active or localized or systemic infections.
- •Subjects must not be immunocompromised.
- •Subjects must not have a coagulation disorder, and must not be using anticoagulation -medications.
- •Subjects must not have history of surgical or cosmetic treatment, including prior skin lightening agents, microneedling or microdermabrasion, or laser or light-based therapies, to the planned treatment areas in the prior 8 weeks.
- •Subjects must not have photosensitivity or allergy.
- •Subjects must not be mentally incompetent.
- •Subjects must not be pregnant or breastfeeding.
- •History of skin cancer or pre-cancerous lesions in the treatment area
- •Subjects must not be currently using aspirin or antioxidants.
- •Subjects must not refuse to sign the Informed Consent document and/or refuse to comply with all follow-up requirements.
- •Subjects must never have had gold therapy.
- •Subjects must never have had radiation therapy to the face. Recent or current suntan or sunburn within 2 weeks.
- •Clinically dysplastic nevi in the treatment area.
- •Subjects must not have had collagen, other methods of tissue augmentation, botox, chemical peels, dermabrasion, or resurfacing within the last year.
- •Oral retinoid (Accutane or Soriatane) or photosensitizing drugs, e.g. Declomycin®, a tetracycline with light absorption in the range of 400 to 450 nm use within 24 months of study entry.
- •Topical retinoid therapy on face within one month of study entry.
- •History of keloids or hypertrophic scars
- •A history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins, or photodermatosis.
结局指标
主要结局
The primary objective of our study is to determine the efficacy of combined topical cysteamine cream with a 1927 diode non-ablative laser (Clear + Brilliant Permea®; Solta Medical, Inc.), compared to topical cysteamine alone in the treatment of melasma.
时间窗: 12 Weeks
Photographic assessment by two blinded dermatologists will measure changes will assess improvement in melasma by modified Melasma Area and Involvement Index (mMASI). Total mMASI score ranges from 0 - 24, with a higher score indicating more involvement and/or severity of melasma
次要结局
未报告次要终点