Effects of a Zinc Oxide Underarm Formula on Normal and Injured Skin: A Randomized and Double-blind Trial in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Growth of Corynebacterium spp. after 8 days of treatment
研究概览
简要总结
Bothersome odor from the axilla is in most cases caused by Corynebacterium spp. Anti-microbial effects of zinc oxide (ZnO) are well documented.
The overall objective of this study is to verify that repeated applications of a ZnO containing formulation can be directly linked to reduced growth of Corynebacterium spp. in the axillae.
详细描述
In the trial the effects of the ZnO formulation on the skin of the forearms and axillae are investigated simultaneously. In both locations the skin is treated daily with the ZnO/placebo formulations.
At day -8 skin areas of the forearms and the axillae are sampled by adhesive tape that is extracted in phosphate-buffered saline (PBS) and PBS extract analyzed on total proteins (BCA) and IL-1α. In the axillae swabs are taken for Corynebacterium spp. semi quantification and pH is measured in the axillae and on the forearm.
At day 0 treated skin areas of the forearms and the axillae are sampled by adhesive tape that is extracted in PBS and PBS extract analyzed on total proteins (BCA) and IL-1α, and compared to adjacent non-treated skin. In the axillae and on the forearms, swabs are first taken for Corynebacterium spp. semi quantification followed by wounding using ablative fractional (10%) carbon dioxide laser at 20 millijoule/microbeam and pediatric lancet. pH is measured in the axillae and on the forearm.
Progress of wound healing is assessed by dermatoscopy at days 3, 4 and 5. At day 5 swabs are taken in the axillae for Corynebacterium spp. semi quantification and pH is measured. Furthermore, skin areas of the axillae are sampled by adhesive tape that is extracted in PBS and PBS extract analyzed on total proteins (BCA) and IL-1α.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females
- •Age between 18 and 65 years
- •Non-smoking
- •Written informed consent
排除标准
- •No current or past skin disorder
- •Immunosuppressive treatment
- •Pregnant and breast feeding women
- •Hypersensitivity to zinc and/or other ingredients in the products
研究组 & 干预措施
control
Formula without ZnO
干预措施: Formula without ZnO (Other)
intervention
Formula with ZnO
干预措施: Formula with ZnO (Other)
结局指标
主要结局
Growth of Corynebacterium spp. after 8 days of treatment
时间窗: Day 0
Skin surface swabs are cultured, and Corynebacterium spp. identified by light microscopy/MALDI-TOF mass spectrometry and semiquantified.
次要结局
- Wound healing(Day 3, day 4 and day 5)
- Quantification of total proteins and interleukin (IL)-1α(Day -8, day 0 and day 5)
- Changes in skin acidity level (pH)(Day -8 and day 5)
- Pain(Day -8, day 0, day 3, day 4 and day 5)
研究者
Lars Nannestad Jorgensen
Professor, MD, DrMedSci
Bispebjerg Hospital