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临床试验/NCT05923996
NCT05923996尚未招募1 期

Fractional Carbon Dioxide Laser Versus Microbotox Injection in the Treatment of Wide Facial Pores: A Split Face Comparative Study

Assiut University0 个研究点目标入组 21 人开始时间: 2024年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
尚未招募
入组人数
21
主要终点
pore score

研究概览

简要总结

  1. Evaluation of fractional Co2 laser as a treatment option for wide pores in skin type (III - VI)
  2. Evaluation of mesobotox as a new modality for improving wide pores appearance.
  3. Comparison of both treatment modalities in treatment of enlarged pores.

详细描述

Skin pores (SP), as they are called by laymen, are common and benign features mostly located on the face (nose, cheeks, etc) that generate many aesthetic concerns or complaints.

Enlarged skin pores refer to conditions that present with visible topographic changes of skin surfaces. Although not a medical concern, enlarged pores are a cosmetic concern for a large number of individuals.

Enlarged facial pores affect individuals of different ages, sexes, and races for which many seek treatment. The exact patho-mechanism of enlarged facial pores is not completely understood. Possible causes include genetic predisposition, seborrhea, aging, increased ultraviolet exposure and comedogenic products.

The treatment of dilated facial pores is difficult, and the ideal modality is not established yet. Many treatment modalities reduce facial pores' count and area, including oral and topical medications as well as different wavelengths of laser. Different ablative and non ablative lasers have been used in the treatment of dilated pores with variable outcomes.

The short-term results showed that treatment with low energy level CO2 fractional laser therapy could be a safe and effective option for patients with Fitzpatrick skin Types III and IV who are concerned with enlarged pores.

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
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with wide facial pores any grade.
  • Sex: male and female patient.
  • Age groups: patient above 18 and below 45 years old.
  • Co-operative patient.

排除标准

  • Patient below 18 and above 45 years old.
  • Patient with systemic illness or other dermatological disease.
  • Patient who receive topical treatment for facial wide pores in past month.
  • Patient who receive systemic treatment for facial wide pores in past 2 month.

研究组 & 干预措施

Microbotox injection

Experimental

21 Egyptian patients with wide facial pores will be treated in a split-face manner. In this side of the face will received single session of microbotox injection contains 20 units of botulinum toxin A.

干预措施: microbotox (Drug)

Fractional carbon dioxide laser in second side of the face

Experimental

21 Egyptian patients with wide facial pores will be treated in a split-face manner. In this side will be treated by Two sessions of the fractional CO2 laser on this side of the face at 4-weeks intervals.

干预措施: fractional carbon dioxide laser (Radiation)

结局指标

主要结局

pore score

时间窗: three months

evaluation of facial pores after four weeks of second session by pore score: score "0" referred to absence of visible pores. score "1" referred to patients with visible pores. score "2" referred to patient with enlarged pores. score "3" referred to patient with black heads when embedded on facial pores.

sebum score

时间窗: three months

evaluation the degree of seborea after four weeks of second session by sebum score: 0 (dry skin) 1. (mild oiliness) 2. (moderate oiliness) 3. (severe oiliness)

Quartile improvement scale

时间窗: three months

assessment the improvement after four weeks of first session and after four weeks of second session by Quartile improvement scale: 0 = No improvement 1. = Minor/mild improvement (1%-25%) 2. = Moderate improvement (26%-50%) 3. = Marked improvement (51%-75%) 4. = Very significant improvement (76%-100%)

次要结局

  • Likert satisfaction scale(three months)

研究者

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

Ahmed Alaa Eldin Ibrahim

doctor

Assiut University

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