Microbiome of the Axillae Clinical Trial
Official title:
Effects of a Zinc Oxide Underarm Formula on Normal and Injured Skin: A Randomized and Double-blind Trial in Healthy Volunteers
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.
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.
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