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临床试验/NCT03170596
NCT03170596已完成不适用

Microneedling Versus Topical Tazarotene 0.1% Gel for the Treatment of Atrophic Post Acne Scarring - a Randomized Controlled Study

Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年6月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Acne scar severity grade at final visit

研究概览

简要总结

Post acne scarring is a common complication of acne. Cosmetic appearance of the post acne facial scarring can be improved by various methods. Among the procedural methods microneedling (1) is a novel and a promising option. It is a minimally invasive day care procedure for the management of atrophic acne scars. Topical tazarotene 0.1% gel is an effective medical method in the management of acne vulgaris and macular acne scars (2, 3). Based on its mechanism of action and role in collagen synthesis, topical tazarotene is a logical choice to investigate for the management of atrophic post acne scars. This is a pilot study comparing microneedling and topical tazarotene for the treatment of atrophic post acne scarring in regard to extent and rapidity of improvement, patient satisfaction and any adverse events if any.

Thirty six subjects with grade 2 to grade 4 atrophic post acne scars, classified on the basis of Goodman's Qualitative classification (4) criteria will be recruited. Goodman's qualitative and quantitative acne scarring grading system scoring will be performed for the assessment of severity of acne scarring at baseline. The face of each patient will be randomized for monthly microneedling on one side and topical tazarotene 0.1 % gel once a day local application on opposite side, using computer generated random number table. Follow ups will be done at every month until treatment completion (3 months) and 3 months after the last treatment session. Goodman's qualitative and quantitative acne scarring grading system scoring will be performed at 3rd and 6th month follow up visits. An improvement by two grades will be considered as excellent, one grade will be rated as good and no up gradation will be labelled as poor response. Patients will be also assessed by a blinded observer for clinical improvement and scored on a scale of 0 (no improvement) to 10 (maximum) at 3rd and 6th month follow up visits with the help of serial photographs taken under consistent background, position and lighting. All patients will be instructed to assess themselves using Patients' Global Assessment Score 0 (no response) to 10 (maximum) at 3rd and 6th month follow up visits.

The investigators hope the outcome of the present study may propose a newer medical modality for acne scarring, i.e topical tazarotene 0.1% gel, which can be used at home, obviating the need for physician dependant microneedling procedure.

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

An independant senior dermatologist who is blinded regarding the modality used for atrophic acne scarring in each half of the face, will be assessing the outcome scores.

入排标准

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

入选标准

  • Patients with grade 2 to grade 4 atrophic acne scars, classified on the basis of Goodman's Qualitative classification.6
  • Should not have undergone any surgical and/or laser treatment for acne scars in the past 1 year.

排除标准

  • Active acne
  • History of keloidal tendency/hypertrophic or keloidal scarring on the face due to acne
  • Facial scars due to reasons other than acne like varicella, trauma, burns etc
  • Collagen vascular disease, bleeding disorders
  • Any active bacterial , fungal or viral infection over face
  • Pregnant and lactating females
  • Known hypersensitivity to tazarotene
  • Age less than 18 years
  • Patients on anticoagulant therapy or aspirin

研究组 & 干预措施

Tazarotene gel arm

Experimental

The treatment protocol in this arm will consist of night time application of Tazarotene 0.1% gel during the entire study period. (3 months)

干预措施: tazarotene gel 0.1% (Drug)

Microneedling arm

Active Comparator

The treatment protocol in this arm will consist of four sessions of microneedling at monthly intervals. (0, 1, 2, 3 months)

干预措施: Microneedling (Device)

结局指标

主要结局

Acne scar severity grade at final visit

时间窗: 6 months

Change in acne scar severity grade from baseline and at 6 months

次要结局

  • Adverse events(6 months)
  • Acne scar severity grade at final visit at 3 months(3 months)
  • Patient satisfaction(6 months)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Tarun Narang

Assistant Professor

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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