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OpenTrials
Completed

NCT Number: NCT03221699

Effects of a Zinc Oxide Underarm Formula on Normal and Injured Skin 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.

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Key information

Conditions

Microbiome of the Axillae

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, Copenhagen NV, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Formula with ZnO

Other

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

Formula without ZnO

Other

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

Primary outcomes

  1. Growth of Corynebacterium spp. after 8 days of treatment

    Time frame: Day 0

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

Secondary outcomes

  1. Wound healing

    Time frame: Day 3, day 4 and day 5

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

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

    Time frame: 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.

  3. Changes in skin acidity level (pH)

    Time frame: Day -8 and day 5

    pH measurements are performed on both axillae

  4. Pain

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

    McGill pain questionnaire

Sponsors and collaborators

Lead sponsor

Lars Nannestad Jorgensen

Other

Collaborators

  • Colgate Palmolive

Registry information

Official study title

Effects of a Zinc Oxide Underarm Formula on Normal and Injured Skin: A Randomized and Double-blind Trial in Healthy Volunteers

Acronym: ZINC-ON

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 18, 2017
Registry last updated
Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.