NCT02904564Unknown4 期
Conventional Microneedling Compared to Microneedling Associated With 5-FU Infusion (Microinfusion of Medication Into the Skin - MMP) for Idiopathic Guttate Hypomelanosis (IGH) Repigmentation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Lesions counting of Idiopathic Guttate Hypomelanosis (IGH)
研究概览
简要总结
The purpose of this study is to determine whether 5-FU infusion (Microinfusion of Medicine Percutaneously - MMP) is effective for Idiopathic Guttate Hypomelanosis (IGH) repigmentation compared to conventional Microneedling. MMP is a procedure done with tattoo devices using medication in place of ink.
详细描述
Split body design. Each upper limb will receive a different intervention (experimental or placebo)
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females, between ages 30 and 70
- •Photodamaged skin on upper limbs with IGH lesions meeting aforementioned criteria and excluding differential diagnosis
- •Fitzpatrick skin types III - V
- •Apt and willing to comply with the entire program as well as appointments, treatment and examination
- •Capable of understanding and providing a written informed consent
- •Fertile women will have to use a viable birth control method for at least 3 months prior to entry and throughout the entire study
排除标准
- •Pregnancy, intention to become pregnant during the course of the study, less than 3 months after delivery or less than 6 weeks after breastfeeding cessation.
- •Uncontrolled comorbidity or any disease that, in the investigator's opinion, may interfere with the treatment, healing or cure.
- •Present symptoms of hormonal disturbances, as per the investigator's criteria.
- •Constitutional photosensitivity or due to metabolic disfunction, or due to use of external agentes (pharmaco, natural products, etc.) prior to initial treatment or during the study.
- •Use of oral isotretinoin 6 months prior to initial treatment or during the course of the study.
- •Prior treatment in target área 3 months prior to initial treatment or during the course of the study.
- •Adverse reaction to any external agentes (gel, lotions or anesthetic creams) required during the study in case no alternative is available for such agent.
- •History of keloids or other type of hypertrophic scar formation or poor wound healing in a previously injured area of skin.
- •History of collagen disease.
- •Displastic nevus or suspicious carcinogenic lesion in área to be treated.
- •Hemmorragic disorder or under anticoagulant medication, including the use of aspirin not permitting a minimum 10-day suspension prior to each treatment period (in accordance with the criteria of the patient's physician).
- •Skin frailty of sensitivity, favoring hemmorrage.
- •History of immunosuppresion / immunological deficiency disorders (including HIV infection) or use of immunosuppressant medication.
- •Participation in a study involving medication or another device three months prior to the study or during enrollment herein.
- •Any condition which, in the investigator's opinion, would jeopardize the study or its participants, such as acute psychiatric disorders, panic syndrome or any aversion to needles or to the procedure.
- •Hypochromiant dermatoses such as vitiligo, pitiriasis, versicolor, albinism.
- •Dermatoses that evolve like Koebner's phenomenon.
- •Cutaneous infectious process at the application site.
研究组 & 干预措施
MMP with 5-FU infusion
Experimental
MMP with 5-FU infusion using tattoo device
干预措施: MMP with 5-FU (Drug)
MMP with saline infusion
Placebo Comparator
MMP with saline infusion using tattoo device
干预措施: MMP with Saline infusion (Drug)
结局指标
主要结局
Lesions counting of Idiopathic Guttate Hypomelanosis (IGH)
时间窗: 30 days
Two assessors will independently count the number of lesions in the treated skin area
次要结局
- Patient satisfaction assessed by Likert scale(30 days)
- Systemic adverse events(24 hours)
- Local adverse events(30 days)
研究者
研究点 (1)
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