Microbiome of the Axillae
Conditions
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.
Interventions
OTHERFormula with ZnO
Forearms and axillae are treated by the volunteers once daily with a standardized amount of the roll-on with ZnO
OTHERFormula without ZnO
Forearms and axillae are treated by the volunteers once daily with a standardized amount of the roll-on without ZnO
Sponsors
Colgate Palmolive
Lars Nannestad Jorgensen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed