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

Not Applicable

Completed

• Conditions: Microbiome of the Axillae
• Interventions: Other: Formula with ZnO; Other: Formula without ZnO

• Registration Number: NCT03221699
• Lead Sponsor: Lars Nannestad Jorgensen

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.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2017-03-22
• Study Completion: 2017-03-22
• Study First Submitted: 2017-03-30
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-14
• Last Update Submitted: 2017-07-14
• Study First Posted: 2017-07-18
• Last Update Posted: 2017-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Formula with ZnO	Formula with ZnO
control	Formula without ZnO	Formula without ZnO

Primary Outcome Measures

Name	Time	Method
Growth of Corynebacterium spp. after 8 days of treatment	Day 0	Skin surface swabs are cultured, and Corynebacterium spp. identified by light microscopy/MALDI-TOF mass spectrometry and semiquantified.

Secondary Outcome Measures

Name	Time	Method
Wound healing	Day 3, day 4 and day 5	Dermatoscopy is used to assess the erythema, crust formation and healing
Quantification of total proteins and interleukin (IL)-1α	Day -8, day 0 and day 5	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.
Changes in skin acidity level (pH)	Day -8 and day 5	pH measurements are performed on both axillae
Pain	Day -8, day 0, day 3, day 4 and day 5	McGill pain questionnaire

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Copenhagen NV, Denmark