Effects of a Zinc Oxide Underarm Formula on Normal and Injured Skin in Healthy Volunteers

Lars Nannestad Jorgensen30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Microbiome of the Axillae

Interventions

Formula with ZnOOTHER

Forearms and axillae are treated by the volunteers once daily with a standardized amount of the roll-on with ZnO

Formula without ZnOOTHER

Forearms and axillae are treated by the volunteers once daily with a standardized amount of the roll-on without ZnO

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Bispebjerg Hospital

Copenhagen, Copenhagen NV, Denmark

Outcomes

Primary Outcomes

Growth of Corynebacterium spp. after 8 days of treatment

Skin surface swabs are cultured, and Corynebacterium spp. identified by light microscopy/MALDI-TOF mass spectrometry and semiquantified.

Time frame: Day 0

Secondary Outcomes

Wound healing

Dermatoscopy is used to assess the erythema, crust formation and healing

Time frame: Day 3, day 4 and day 5

Quantification of total proteins and interleukin (IL)-1α

Corneocytes are sampled on both forearms and axillae by adhesive tape (Sebutape®; CuDerm, Dallas, Texas, USA) for quantification of total proteins (BCA) and IL-1α levels by ELISA.

Time frame: Day -8, day 0 and day 5

Changes in skin acidity level (pH)

pH measurements are performed on both axillae

Time frame: Day -8 and day 5

Pain

McGill pain questionnaire

Time frame: Day -8, day 0, day 3, day 4 and day 5

Data from ClinicalTrials.gov

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