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

NCT ID: NCT03221699

Last Updated: 2017-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2017-03-22

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.

Conditions

Microbiome of the Axillae

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

control

Formula without ZnO

Group Type: PLACEBO_COMPARATOR

Formula without ZnO

Intervention Type: OTHER

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

intervention

Formula with ZnO

Group Type: ACTIVE_COMPARATOR

Formula with ZnO

Intervention Type: OTHER

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

Interventions

Formula with ZnO

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

Intervention Type: OTHER

Formula without ZnO

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: collaborator

Lars Nannestad Jorgensen

OTHER

Sponsor Role: lead

Responsible Party

Lars Nannestad Jorgensen

Professor, MD, DrMedSci

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lars N Joergensen

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

Bispebjerg Hospital

Copenhagen, Copenhagen NV, Denmark

Countries

Denmark

Other Identifiers

H-16045754

Identifier Type: -

Identifier Source: org_study_id