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

Microbiome of the Axillae Clinical Trial

— ZINC-ON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03221699
• Other study ID #: H-16045754
• Status: Completed
• Phase: N/A
• First received: March 30, 2017
• Last updated: July 14, 2017
• Start date: February 1, 2017
• Est. completion date: March 22, 2017

Study information

• Verified date: July 2017
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 22, 2017
• Est. primary completion date: March 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Microbiome of the Axillae

Intervention

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

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	Copenhagen NV

Sponsors (2)

Lead Sponsor	Collaborator
Lars Nannestad Jorgensen	Colgate Palmolive

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Wound healing	Dermatoscopy is used to assess the erythema, crust formation and healing	Day 3, day 4 and day 5
Secondary	Quantification of total proteins and interleukin (IL)-1a	Corneocytes are sampled on both forearms and axillae by adhesive tape (Sebutape®; CuDerm, Dallas, Texas, USA) for quantification of total proteins (BCA) and IL-1a levels by ELISA.	Day -8, day 0 and day 5
Secondary	Changes in skin acidity level (pH)	pH measurements are performed on both axillae	Day -8 and day 5
Secondary	Pain	McGill pain questionnaire	Day -8, day 0, day 3, day 4 and day 5