Effects of a Zinc Oxide Underarm Formula on Normal and Injured Skin in Healthy Volunteers (ZINC-ON)

Lars Nannestad Jorgensen

Status: Completed

Conditions: Microbiome of the Axillae

Treatments: Other: Formula with ZnO; Other: Formula without ZnO

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03221699

H-16045754

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

control

Placebo Comparator group

Description:

Formula without ZnO

Treatment:

Other: Formula without ZnO

intervention

Active Comparator group

Description:

Formula with ZnO

Treatment:

Other: Formula with ZnO