Clinical trial NCT03221699: Effects of a Zinc Oxide Underarm Formula on Normal and Injured Skin in Healthy Volunteers
Official title: Effects of a Zinc Oxide Underarm Formula on Normal and Injured Skin: A Randomized and Double-blind Trial in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbiome of the Axillae
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Colgate Palmolive
First posted: 2017-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Healthy males and females
* Age between 18 and 65 years
* Non-smoking
* Written informed consent

Exclusion Criteria:

* No current or past skin disorder
* Immunosuppressive treatment
* Pregnant and breast feeding women
* Hypersensitivity to zinc and/or other ingredients in the products

Primary outcomes:
measure: Growth of Corynebacterium spp. after 8 days of treatment
timeFrame: Day 0
Secondary outcomes:
measure: Wound healing
timeFrame: Day 3, day 4 and day 5
measure: Quantification of total proteins and interleukin (IL)-1α
timeFrame: Day -8, day 0 and day 5
measure: Changes in skin acidity level (pH)
timeFrame: Day -8 and day 5
measure: Pain
timeFrame: Day -8, day 0, day 3, day 4 and day 5
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen NV
Study officials:
affiliation: Bispebjerg Hospital
name: Lars N Joergensen
role: PRINCIPAL_INVESTIGATOR
References: