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临床试验/NCT03779295
NCT03779295撤回不适用

Laser Therapy for Perioral Dermatitis

West Virginia University1 个研究点 分布在 1 个国家开始时间: 2018年11月1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
撤回
试验地点
1
主要终点
Change in number of lesions on side of the subject's face receiving laser therapy

研究概览

简要总结

Perioral dermatitis is an inflammation of the skin around the mouth. The cause of perioral dermatitis is unknown. Current treatment methods include oral antibiotics and topical calcenurin inhibitors, both of which produce side effects and have been relatively ineffective in the treatment of perioral dermatitis. The investigators hope to assess the efficacy of laser therapy in treatment of perioral dermatitis by using laser therapy on one half of the patients face and having patients apply topical medication (clindamycin) to their face for 8 weeks. The side of their face that receives laser therapy will be randomized. The investigators will assess the efficacy of laser therapy by counting the number of lesions that patients have before and after laser therapy, comparing photos of patient's perioral dermatitis before and after treatment, and having patient's rate their satisfaction of the treatment.

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)

盲法说明

The investigators will not remind the participant or other investigators which side of the face received laser therapy, however the investigators cannot completely "blind" either the participant or other investigators as they will be awake or performing the therapy, respectively.

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

  • age 18 years or older
  • perioral dermatitis for greater than 1 month
  • willing to return for follow-up visits 2 weeks, 4 weeks and 8 weeks following treatment.

排除标准

  • skin type V or VI (due to risk of hyperpigmentation)
  • breastfeeding
  • unable to understand English
  • mentally impaired
  • incarcerated

研究组 & 干预措施

Pulse laser therapy

Experimental

Pulse laser therapy will be randomly applied to right side or left side of face in addition to Clindamycin

干预措施: Clindamycin (Drug)

Clindamycin

Experimental

Clindamycin only applied to side of face that does not receive pulse laser therapy.

干预措施: Clindamycin (Drug)

结局指标

主要结局

Change in number of lesions on side of the subject's face receiving laser therapy

时间窗: 8 weeks

counting number of lesions on each side of the face

Change in number of lesions on side of the subject's face receiving clindamycin alone (NO laser therapy)

时间窗: 8 weeks

counting number of lesions on each side of the face

次要结局

  • Patient opinion of side that improved more(8 weeks)

研究者

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

Erica Ghareeb

Assistant Professor

West Virginia University

研究点 (1)

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