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

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.

Study Overview

• Status: Completed
• Conditions: Microbiome of the Axillae
• Intervention / Treatment: Other: Formula without ZnO; Other: Formula with ZnO

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen NV
    • Copenhagen, Copenhagen NV, Denmark, 2400
      • Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: control; Formula without ZnO	Other: Formula without ZnO; Forearms and axillae are treated by the volunteers once daily with a standardized amount of the roll-on without ZnO
ACTIVE_COMPARATOR: intervention; Formula with ZnO	Other: Formula with ZnO; Forearms and axillae are treated by the volunteers once daily with a standardized amount of the roll-on with ZnO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing	Dermatoscopy is used to assess the erythema, crust formation and healing	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.	Day -8, day 0 and day 5
Changes in skin acidity level (pH)	pH measurements are performed on both axillae	Day -8 and day 5
Pain	McGill pain questionnaire	Day -8, day 0, day 3, day 4 and day 5

Collaborators and Investigators

• Sponsor: Lars Nannestad Jorgensen
• Collaborators: Colgate Palmolive
• Investigators: Principal Investigator: Lars N Joergensen, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): March 22, 2017
• Study Completion (ACTUAL): March 22, 2017

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: July 14, 2017
• First Posted (ACTUAL): July 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2017
• Last Update Submitted That Met QC Criteria: July 14, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: H-16045754

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No