跳至主要内容
临床试验/NCT02597777
NCT02597777已完成不适用

Pilot Randomized Double-Blind Controlled Trial of Topical Acetyl Hexapeptide-8 and the Cosmetic Appearance of Oily Skin

University of California, Davis2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Physician graded shine score

研究概览

简要总结

This is a randomized double-blinded study examining the effect of topical Acetyl Hexapeptide-8 AH8) for improving the cosmetic appearance and experience of oily skin.

详细描述

The purpose of this randomized double-blinded study is to investigate whether topical Acetyl Hexapeptide-8 can improve oily skin. Up to 15 adult subjects will be recruited. Each half of the face will randomized to receive either topical treatment with AH8 10% Lotion formulated in Cetaphil® Moisturizing Facial Lotion or the placebo vehicle treatment consisting of Cetaphil® Moisturizing Facial Lotion only, at twice daily application for 4 weeks.

The study consists of a total of 3 sessions: baseline visit, and at 2 weeks and 4 weeks for follow up assessment. Subjects will also be asked to complete an Oily Skin Self-Assessment Scale (OSSAS) and an Oily Skin Impact Scale (OSIS) survey at the first session. They will be filling out two OSSAS surveys (one for each side of the face) at the second and third sessions. The OSSAS survey includes subjective assessment of four components of oily skin: visual, blotting, tactile, and sensation. At each visit, the cosmetic appearance the facial skin will be scored clinically by a dermatologist using a validated 3-point scale for shine (1 = high, 2, moderate or 3 = low), and oiliness (1 = normal, 2 = easily visible or 3 = extensive) 16. High-resolution digital photographs of the facial skin with the use of photography and facial analysis instrumentation will be taken at baseline and at each visit to document facial appearance and for image analysis of shine level. Sebum of the left and right cheeks will be measured by a sebumeter to correlate to the oily appearance noted on the high resolution facial photographs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Subjects over the age of 18

排除标准

  • Recent intradermal botulinum neurotoxin injection within the last 6 months.
  • Known hypersensitivity to AH8
  • Ablative resurfacing procedures to the face within 6 months of the study initiation
  • Report of pregnancy or breastfeeding
  • Use of immunosuppressive drugs

结局指标

主要结局

Physician graded shine score

时间窗: 4 weeks

次要结局

  • Sebum measurement(4 weeks)
  • Physician graded shine score(2 weeks)
  • Patient satisfaction rated by each patient using the Oily Skin Impact Scale (OSIS)(4 weeks)
  • Assessment for local irritation from the topical emulsions(4 weeks)
  • Physician graded oiliness score(4 weeks)
  • Patient satisfaction rated by each patient using the Oily Skin Self-Assessment Scale (OSSAS)(4 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验