跳至主要内容
临床试验/NCT03514771
NCT03514771已完成不适用

Early Non-Ablative Fractional Laser Resurfacing for Acne Scars After Treatment With Oral Isotretinoin

David Smart0 个研究点目标入组 15 人开始时间: 2016年1月28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
15
主要终点
The adverse events associated with early non-ablative fractional laser resurfacing (NAFR) for mild-moderate acne scars after treatment with oral isotretinoin compared to control (non-treated side of the face).

研究概览

简要总结

Patients who have completed have completed a cumulative dose of >=120miligram/kilogram oral isotretinoin within the last 30 days, and has mild to moderate acne scarring will be randomized, into a right-left comparison study using Fraxel DUAL (Solta Medical) laser on one side of the face, and no treatment on the other side of the face. Subejcts will receive treatments at week 0, week 4, and week 8. Photographs will be taken after each treatment, 7 days after each treatment, and 4 months after last treatment. Photographs will be reviewed by blind assessors who will analyze the pre- and post-treatment photographs to measure change.

详细描述

Approximately 15 patients who are over 18 years or older, have completed a cumulative dose of >=120miligram/kilogram oral isotretinoin within the last 30 days, and has mild to moderate acne scarring will be randomized, into a right-left comparison study.

One side of the face will be randomized to NAFR treatment and other side to control (no treatment) using a random number generator. Subjects will apply topical anesthetic (Benzocaine / Lidocaine / Tetracaine 20% / 8% / 4% Ointment) to the entire face one hour prior to treatment. The NAFR operator will be notified of which side is to be treated with NAFR.

To ensure blinded evaluations, the same unblinded investigator will perform all the laser treatments, whereas efficacy evaluations will be performed by two trained and experienced evaluators who are blinded to the treatment assignment. Evaluations for adverse effects will be carried out by the unblinded NAFR (during and immediately post treatment) and the two blinded investigators at prescribed intervals.

Treatments:

Laser procedure will be performed to the entire assigned half of the face with Fraxel DUAL (Solta Medical) with the following settings: 1550 nanometer; 35 to 40 millijoules/microthermal zone, treatment level from 7 to 10, corresponding to treatment coverage of 20% to 35%. The treatment protocol was modified slightly depending on the individual scar characteristics (depth, width, and type).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Efficacy evaluations of photographs will be performed by two trained and experienced evaluators who are blinded to which side of the face has been treated, and which side of the face has not been treated.

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

  • 18 years or older
  • Completed cumulative dose of >=120 miligram/kilogram oral isotretinoin within the last 30 days
  • Mild-moderate acne scarring of all types (icepick, boxcar, rolling)

排除标准

  • Pregnant or nursing women
  • History of porphyria, allergy to porphyrins, or photodermatosis
  • Active infectious disease
  • Severe acne scarring
  • Propensity to hypertrophic or keloid scarring
  • Immunosuppression
  • Laser or any cosmetic treatment in the previous 6 months

研究组 & 干预措施

All Subjects

Other

All subjects will have one side of their face treated with the laser and one side not treated to serve as the control.

干预措施: Fraxel DUAL 1550/1927 (Device)

All Subjects

Other

All subjects will have one side of their face treated with the laser and one side not treated to serve as the control.

干预措施: oral isotretinoin (Drug)

All Subjects

Other

All subjects will have one side of their face treated with the laser and one side not treated to serve as the control.

干预措施: oral valacyclovir (Drug)

结局指标

主要结局

The adverse events associated with early non-ablative fractional laser resurfacing (NAFR) for mild-moderate acne scars after treatment with oral isotretinoin compared to control (non-treated side of the face).

时间窗: Baseline visit through 4 month follow-up

Adverse Events

次要结局

  • To evaluate the efficacy of early non-ablative fractional laser resurfacing (NAFR) for mild-moderate acne scars after treatment with oral isotretinoin compared to control (non-treated side of the face).(up to 4-months follow up)

研究者

发起方
David Smart
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David Smart

Principal Investigator

University of Utah

相似试验