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临床试验/NCT03923062
NCT03923062Unknown4 期

Different Dermatological Approaches in Treatment of Melasma: A Split Face Randomized Clinical Trial

Assiut University0 个研究点目标入组 40 人开始时间: 2020年2月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
40
主要终点
melasma area and severity index (MASI)

研究概览

简要总结

To compare the efficacy and safety of cryopeeling (using Liquid Nitrogen) and tranexemic acid (cyclokapron) versus chemical peeling (using TCA 20%) in treatment of melasma.

详细描述

Melasma is a common, acquired, circumscribed hypermelanosis of the sun-exposed skin, It presents as symmetric, hyperpigmented macules having irregular, serrated, and geographic borders , The most common locations are the cheeks, upper lips, the chin and the forehead, but other sun-exposed areas may also be occasionally involved .

Studies has indicated the role of several risk factors such as genetics, sunlight, age, gender, hormones, pregnancy, thyroid dysfunction, cosmetics and medications .

Histologic features of melasma include an increase in the content of both epidermal and dermal melanin, but the quantity varies with the intensity of hyperpigmentation. In addition, most studies show no quantitative increase in melanocytes; however, the cells are enlarged with prominent and elongated dendrites and more abundant melanosomes. Additional features of the involved skin include solar elastosis and increased mast cells, dermal blood vessels, and expression of vascular endothelial growth factor.

Commonly used topical agents for the treatment of melasma include hydroquinone, azelaic acid, kojic acid, glycolic acid, salicylic acid and tretinoin. Of these treatments, hydroquinone remains the gold standard .Second-line treatments, such as chemical peels and lasers, are efficacious in some patients .

Chemical peeling is the application of a chemical agent to the skin, which causes the controlled destruction of a part or of the entire epidermis with or without the dermis, leading to exfoliation and removal of superficial lesions, followed by regeneration of new epidermal and dermal tissues [khunger, 2008]. The mechanism of action in melasma is the removal of unwanted melanin via controlled chemical burn of the skin .

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
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •-Subjects presented with melasma.
  • •Age 20-40 years old.
  • •Melasma persisting for more than 6 months that has failed to respond to conventional treatment with hydroquinone or other topical lightening agents.

排除标准

  • •-History of photosensitivity, keloids, hypertrophic scarring and post- inflammatory hyperpigmentation.
  • •Pregnancy and lactation.
  • •Subjects with local inflammatory skin disorder or active herpes infection at the site of procedure.
  • •Subjects with history of medical diseases which contraindicate cryosurgery such as; cold intolerance, cold urticaria, Raynaud's disease and history of allergic reactions to cryosurgery.

研究组 & 干预措施

G I A (right side): will be treated by chemical peeling

Experimental

right sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration).

干预措施: chemicalpeeling (Device)

G I B(left side):will be treated by cryopeeling

Experimental

left side of the patient's face will be treated by cryopeeling using Liquid Nitrogen.

干预措施: cryopeeling (Device)

G II A (right side): will be treated by chemical peeling

Experimental

right sideof patient's face will be treated by chemical peeling( Trichloroacetic acid 20% concentration).

干预措施: chemicalpeeling (Device)

G II B (left side):will be treated by tranexemic acid

Experimental

left side of patient's face will be treated by tranexemic acid(cyclokapron)

干预措施: microneedling (Combination Product)

结局指标

主要结局

melasma area and severity index (MASI)

时间窗: baseline

Clinical evaluation of melasma severity will be done by melasma area severity index (MASI) every session and at the end of treatment. No response, no improvement. * Mild response, \<25% improvement. * Moderate response, 25% to \< 50% improvement. * Good response, 50% to \< 75% improvement. * Very good response, \>75% improvement.

photo of the patient

时间窗: baseline

photo of the patient before and after treatment

Biopsy

时间窗: baseline

A punch biopsy will be taken from affected area for histipathological examination

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shimaa Hafez

Principle investigator

Assiut University

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