Microbiome of the AxillaeZINC-ONNCT03221699
Effects of a Zinc Oxide Underarm Formula on Normal and Injured Skin in Healthy Volunteers
A study testing Formula with ZnO and Formula without ZnO in people with Microbiome of the Axillae, run by Lars Nannestad Jorgensen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiome of the Axillae
- What is being tested?
- Formula with ZnO and Formula without ZnO
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2017to 22 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females
- Age between 18 and 65 years
- Non-smoking
- Written informed consent
Who cannot join
- No current or past skin disorder
- Immunosuppressive treatment
- Pregnant and breast feeding women
- Hypersensitivity to zinc and/or other ingredients in the products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Zinc Oxide Underarm Formula on Normal and Injured Skin: A Randomized and Double-blind Trial 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.
Read the 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
- Being tested
- Formula with ZnO, Formula without ZnO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formula with ZnOOther
Forearms and axillae are treated by the volunteers once daily with a standardized amount of the roll-on with ZnO
Formula without ZnOOther
Forearms and axillae are treated by the volunteers once daily with a standardized amount of the roll-on without ZnO
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | Formula without ZnO Receives: Other: Formula without ZnO |
| intervention | Active comparator | Formula with ZnO Receives: Other: Formula with ZnO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (4)
Wound healing
Dermatoscopy is used to assess the erythema, crust formation and healing
Measured: Day 3, day 4 and day 5
Quantification of total proteins and interleukin (IL)-1α
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.
Measured: Day -8, day 0 and day 5
Changes in skin acidity level (pH)
pH measurements are performed on both axillae
Measured: Day -8 and day 5
Pain
McGill pain questionnaire
Measured: Day -8, day 0, day 3, day 4 and day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Feb 2017
- Primary completion22 Mar 2017
- Study completion22 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbiome of the AxillaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lars Nannestad Jorgensen
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive
- Responsible party
- Sponsor-investigator, Lars Nannestad Jorgensen, Bispebjerg Hospital
- Investigators
- Lars N Joergensen, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221699
- Sponsor's protocol ID
- H-16045754
- Acronym
- ZINC-ON
- Status last verified
- Jul 2017
- First submitted
- 30 Mar 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Zinc Oxide Underarm Formula on Normal and Injured Skin: A Randomized and Double-blind Trial in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03221699
- Acronym / sponsor ID
- ZINC-ON / H-16045754
- Conditions
- Microbiome of the Axillae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lars Nannestad JorgensenUniversity, hospital or other
- Collaborators
- Colgate Palmolive
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 22 Mar 2017 (actual)
- Study completion
- 22 Mar 2017 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Other: Formula without ZnOFormula without ZnO |
| intervention | Active comparator | Other: Formula with ZnOFormula with ZnO |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy males and females
- Age between 18 and 65 years
- Non-smoking
- Written informed consent
Key exclusion criteria (4 listed)
- No current or past skin disorder
- Immunosuppressive treatment
- Pregnant and breast feeding women
- Hypersensitivity to zinc and/or other ingredients in the products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formula with ZnOForearms and axillae are treated by the volunteers once daily with a standardized amount of the roll-on with ZnO | Other | intervention |
| Formula without ZnOForearms and axillae are treated by the volunteers once daily with a standardized amount of the roll-on without ZnO | Other | control |
Primary outcome
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.
4 secondary outcomes
Wound healing
Time frame: Day 3, day 4 and day 5
Quantification of total proteins and interleukin (IL)-1α
Time frame: Day -8, day 0 and day 5
Changes in skin acidity level (pH)
Time frame: Day -8 and day 5
Pain
Time frame: Day -8, day 0, day 3, day 4 and day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars N Joergensen principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formula with ZnO and Formula without ZnO in people with Microbiome of the Axillae, run by Lars Nannestad Jorgensen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth of Corynebacterium spp. after 8 days of treatment (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.