Microneedling for Acquired Hypomelanosis : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Efficacy of microneedling for acquired hypomelanosis assessed by visual analogue scale for surface tanning
研究概览
简要总结
Acquired hypomelanosis is a type of cutaneous melanocytopenic hypomelanosis, denoting the lightening of the skin due to a reduction in the number of epidermal and/or follicular melanocytes secondary to physical agents,post-inflammatory, and iatrogenic (steroids).
Derma roller is the basic device of microneedling , performs superficial, controlled puncturing of the skin by rolling with miniature fine needles and used as a collagen induction therapy and a transdermal delivery system for therapeutic drugs and vaccines.
This minute trauma to the skin that activates regenerative mechanisms and wound healing by releasing growth factors. The release of cytokines and deposition of hemosiderin from dermal bleeding induce the activation of melanocyte and stimulate skin pigmentation plus transdermal traveling of melanocyte
详细描述
The aim of this study to evaluate the efficacy and safety of microneedling as a treatment model for patients with acquired hypomelanosis.
Patients with an acquired hypomelanosis from outpatient clinic, department of dermatology, Cairo university,n=20. including:
▪Patients, both genders and older than 18 years with localized acquired hypomelanosis
Excluding:
- Congenital and hereditary hypomelanosis.
- Vitiligo
- Pregnancy and lactation.
- Patients with a history of any autoimmune disease.
- Patients with a history of keloid formation.
- Patient on systemic steroids, retinoids, immunosuppressant or anticoagulant therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Localized acquired hypomelanosis secondary to any insult, post-inflammatory or iatrogenic of no more than 2 years duration, affecting any anatomical site except genitalia, of any size larger than 3 cm in diameter.
- •Patients older than 18 years old, consenting to go through the microneedling procedure.
- •Both genders.
- •Exclusion criteria:
- •Congenital and hereditary hypomelanosis.
- •Pregnancy and lactation.
- •Patients with history of any autoimmune disease.
- •Patients with history of keloids formation.
- •Patient on systemic steroids, retinoids, immunosuppressant or anticoagulant therapy.
排除标准
- 未提供
结局指标
主要结局
Efficacy of microneedling for acquired hypomelanosis assessed by visual analogue scale for surface tanning
时间窗: 3 months post treatment
using hue skin tone color scale
Efficacy of microneedling for acquired hypomelanosis assessed by the patient's satisfaction score
时间窗: 3 months post treatment
3-point scale (not satisfied, moderately satisfied, extremely satisfied).
Efficacy of microneedling for acquired hypomelanosis assessed by patient global percent of his own improvement(0-100%).
时间窗: 3 months post treatment
the patient evaluation to lesion by percentage value for repigmentation ranged from 0- 100% which represent full repigmentation.
Efficacy of microneedling for acquired hypomelanosis assessed by mean physician's global assessment for percent of improvement (0-100%).
时间窗: 3 moonths post treatment.
One unblinded and 2 blinded investigators assessed the global improvement through photographs of the lesions before and after 3 months of therapy. The lesions were photographed on a black background using a single reflex camera with standardized settings (ambient light, same position, and distance from the patient).
Efficacy of microneedling for acquired hypomelanosis assessed by vitiligo extent score for a target area for marginal and perifollicular repigmentation.
时间窗: 3 months post treatment
The repigmentation assessed by percentage value range from 0- 100% where the 100 % means full repigmentation, the value is a result of an equation where the estimated percentage of marginal repigmentation add to ( remaining area (%) plus estimated percent of perifollicular pigmentation in the remaining area(%) divided by 100)
Efficacy of microneedling for acquired hypomelanosis assessed by skin mapping for peripheral tanning.
时间窗: 3 months post treatment
drawing the lesion's surface area through transparent stencil paper
次要结局
- Incidence of microneedling adverse events(Day 1 to 14 and after 3 months.)
研究者
Julbahar Ibrahim
Dermatology resident,Principal investigator-Cairo university.
Cairo University