Denuded EpidermisPhase 2ZINGELNCT02116725
Zinc Gel and Epidermal Regeneration in Healthy Human Volunteers
A Phase 2 study testing Shower gel with zinc, Plain shower gel and Distilled water in people with Denuded Epidermis, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Zinc is an important metal for the maintenance of healthy skin and wound healing. Washing with detergents e.g. shower gels may deplete the zinc stores in the skin. The purpose of our study is to see whether repeated washing with zinc containing shower gel of superficial wounds will result in increased healing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Denuded Epidermis
- What is being tested?
- Shower gel with zinc, Plain shower gel and Distilled water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Sep 2014
- Phase
- Phase 2
- 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 male and female volunteers
- Age between18 and 65 years
- Written informed consent
Who cannot join
- Smoker
- Active skin disease in test areas
- Hypersensitivity to zinc or any of the shower gel ingredients
- Immunosuppressive treatment
- Pregnant or breastfeeding females
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Digestive Disease Center and Copenhagen Wound Healing Center, University of Copenhagen
Copenhagen, DK-2400
Heidi F Larsen, MD, (+45) 35313531
Lars N Jørgensen, MD, DMSc
About this study
Official title: Effects of Shower Gel With Zinc on Epidermal Regeneration
Zinc is an important metal for the maintenance of healthy skin and wound healing. Washing with detergents e.g. shower gels may deplete the zinc stores in the skin.
The purpose of our study is to see whether repeated washing with zinc containing shower gel of superficial wounds will result in increased healing.
Read the detailed description
Zinc is a trace element abundantly present in skin with a concentration gradient from the upper stratum corneum layer to the basal layer. This fact probably reflects the necessity for zinc as co-factor in numerous enzymes involved in skin homeostasis and wound healing. Theoretically, showering with surfactants increases the loss of zinc by the shedding of the zinc-rich corneocytes. Thus there is a concern that this forced exfoliation will result in suboptimal zinc levels for the maintenance of physiological processes involved in epidermal homeostasis and repair. A logical development would thus be to supplement shower gel with zinc to compensate for this loss.
In 30 healthy volunteers one epidermal wound (10 mm in diameter) is induced by suction and heat on each buttock. The wounds are washed with shower gel containing zinc, placebo shower gel or water (reference). The treatments are allocated by randomization ensuring that 20 wounds are washed with shower gel containing zinc, 20 wounds are washed with placebo shower gel and 20 wounds are washed with water.
- Conditions
- Denuded Epidermis
- Being tested
- Shower gel with zinc, Plain shower gel, Distilled water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shower gel with zincOther
Standard shower gel (Sanex) supplemented with zinc sulfate.
Plain shower gelOther
Standard shower gel (Sanex).
Distilled waterOther
Sterile distilled Water.
| Study group | Role | What they receive |
|---|---|---|
| Shower gel with zinc | Experimental | Zinc gel is applied daily (50 µl/cm2) to wound and surrounding noninjured skin. Receives: Other: Shower gel with zinc |
| Plain shower gel | Placebo comparator | Plain shower gel is applied daily (50 µl/cm2) to wound and surrounding noninjured skin. Receives: Other: Plain shower gel |
| Distilled water | Sham comparator | Distilled Water is applied daily (50 µl/cm2) to wound and surrounding noninjured skin. Receives: Other: Distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidermal regeneration
Epidermal regeneration will be assessed blindly by histomorphometry in hematoxylin-eosin-stained paraffin sections of the wounds and by optical coherence tomography.
Measured: Day 4
Secondary outcomes (5)
Bacterial growth
Swabs are taken from wounds and adjacent, treated skin.
Measured: Day 4
Skin barrier function
Skin barrier function is measured by transepidermal water loss by an instrument from Cortex.
Measured: Day 4
Keratinocyte proliferation
Immunohistochemical detection of Ki67 in paraffin sections of the wounds using mouse monoclonal antibody (MIB-1).
Measured: Day 4
Matrix metalloproteinase (MMP)-1 expression
Immunohistochemical detection of MMP-1 in paraffin sections of the wounds using mouse monoclonal antibody.
Measured: Day 4
Pain
Pain is assessed on a VAS scale (0-100 mm) by the participant.
Measured: Days 0, 1, 2, 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Denuded EpidermisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Nannestad Jorgensen, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116725
- Sponsor's protocol ID
- ERS-2013-01-LDT
- Acronym
- ZINGEL
- Status last verified
- Apr 2014
- First submitted
- 15 Apr 2014
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lansdown AB, Mirastschijski U, Stubbs N, Scanlon E, Agren MS. Zinc in wound healing: theoretical, experimental, and clinical aspects. Wound Repair Regen. 2007 Jan-Feb;15(1):2-16. doi: 10.1111/j.1524-475X.2006.00179.x.
PubMed 17244314Woodley DT, Kim YH. A double-blind comparison of adhesive bandages with the use of uniform suction blister wounds. Arch Dermatol. 1992 Oct;128(10):1354-7.
PubMed 1417023Agren MS, Mirastschijski U, Karlsmark T, Saarialho-Kere UK. Topical synthetic inhibitor of matrix metalloproteinases delays epidermal regeneration of human wounds. Exp Dermatol. 2001 Oct;10(5):337-48. doi: 10.1034/j.1600-0625.2001.100506.x.
PubMed 11589731Malminen M, Koivukangas V, Peltonen J, Karvonen SL, Oikarinen A, Peltonen S. Immunohistological distribution of the tight junction components ZO-1 and occludin in regenerating human epidermis. Br J Dermatol. 2003 Aug;149(2):255-60. doi: 10.1046/j.1365-2133.2003.05438.x.
PubMed 12932229Agren MS, Chvapil M, Franzen L. Enhancement of re-epithelialization with topical zinc oxide in porcine partial-thickness wounds. J Surg Res. 1991 Feb;50(2):101-5. doi: 10.1016/0022-4804(91)90230-j.
PubMed 1990212Ferraq Y, Black DR, Theunis J, Mordon S. Superficial wounding model for epidermal barrier repair studies: comparison of Erbium:YAG laser and the suction blister method. Lasers Surg Med. 2012 Sep;44(7):525-32. doi: 10.1002/lsm.22054. Epub 2012 Aug 1.
PubMed 22865469
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Shower Gel With Zinc on Epidermal Regeneration
- ClinicalTrials.gov ID
- NCT02116725
- Acronym / sponsor ID
- ZINGEL / ERS-2013-01-LDT
- Conditions
- Denuded Epidermis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 17 Apr 2014 (estimated)
- 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.
Zinc is an important metal for the maintenance of healthy skin and wound healing. Washing with detergents e.g. shower gels may deplete the zinc stores in the skin.
The purpose of our study is to see whether repeated washing with zinc containing shower gel of superficial wounds will result in increased healing.
Detailed description
Zinc is a trace element abundantly present in skin with a concentration gradient from the upper stratum corneum layer to the basal layer. This fact probably reflects the necessity for zinc as co-factor in numerous enzymes involved in skin homeostasis and wound healing. Theoretically, showering with surfactants increases the loss of zinc by the shedding of the zinc-rich corneocytes. Thus there is a concern that this forced exfoliation will result in suboptimal zinc levels for the maintenance of physiological processes involved in epidermal homeostasis and repair. A logical development would thus be to supplement shower gel with zinc to compensate for this loss.
In 30 healthy volunteers one epidermal wound (10 mm in diameter) is induced by suction and heat on each buttock. The wounds are washed with shower gel containing zinc, placebo shower gel or water (reference). The treatments are allocated by randomization ensuring that 20 wounds are washed with shower gel containing zinc, 20 wounds are washed with placebo shower gel and 20 wounds are washed with water.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shower gel with zinc | Experimental | Other: Shower gel with zincZinc gel is applied daily (50 µl/cm2) to wound and surrounding noninjured skin. |
| Plain shower gel | Placebo comparator | Other: Plain shower gelPlain shower gel is applied daily (50 µl/cm2) to wound and surrounding noninjured skin. |
| Distilled water | Sham comparator | Other: Distilled waterDistilled Water is applied daily (50 µl/cm2) to wound and surrounding noninjured skin. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male and female volunteers
- Age between18 and 65 years
- Written informed consent
Key exclusion criteria (5 listed)
- Smoker
- Active skin disease in test areas
- Hypersensitivity to zinc or any of the shower gel ingredients
- Immunosuppressive treatment
- Pregnant or breastfeeding females
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 |
|---|---|---|
| Shower gel with zincStandard shower gel (Sanex) supplemented with zinc sulfate. | Other | Shower gel with zinc |
| Plain shower gelStandard shower gel (Sanex). | Other | Plain shower gel |
| Distilled waterSterile distilled Water. | Other | Distilled water |
Primary outcome
Epidermal regeneration
Time frame: Day 4
Epidermal regeneration will be assessed blindly by histomorphometry in hematoxylin-eosin-stained paraffin sections of the wounds and by optical coherence tomography.
5 secondary outcomes
Bacterial growth
Time frame: Day 4
Skin barrier function
Time frame: Day 4
Keratinocyte proliferation
Time frame: Day 4
Matrix metalloproteinase (MMP)-1 expression
Time frame: Day 4
Pain
Time frame: Days 0, 1, 2, 3 and 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
- Background: PubMed 17244314Lansdown AB, Mirastschijski U, Stubbs N, Scanlon E, Agren MS. Zinc in wound healing: theoretical, experimental, and clinical aspects. Wound Repair Regen. 2007 Jan-Feb;15(1):2-16. doi: 10.1111/j.1524-475X.2006.00179.x.
- Background: PubMed 1417023Woodley DT, Kim YH. A double-blind comparison of adhesive bandages with the use of uniform suction blister wounds. Arch Dermatol. 1992 Oct;128(10):1354-7.
- Background: PubMed 11589731Agren MS, Mirastschijski U, Karlsmark T, Saarialho-Kere UK. Topical synthetic inhibitor of matrix metalloproteinases delays epidermal regeneration of human wounds. Exp Dermatol. 2001 Oct;10(5):337-48. doi: 10.1034/j.1600-0625.2001.100506.x.
- Background: PubMed 12932229Malminen M, Koivukangas V, Peltonen J, Karvonen SL, Oikarinen A, Peltonen S. Immunohistological distribution of the tight junction components ZO-1 and occludin in regenerating human epidermis. Br J Dermatol. 2003 Aug;149(2):255-60. doi: 10.1046/j.1365-2133.2003.05438.x.
- Background: PubMed 1990212Agren MS, Chvapil M, Franzen L. Enhancement of re-epithelialization with topical zinc oxide in porcine partial-thickness wounds. J Surg Res. 1991 Feb;50(2):101-5. doi: 10.1016/0022-4804(91)90230-j.
- Background: PubMed 22865469Ferraq Y, Black DR, Theunis J, Mordon S. Superficial wounding model for epidermal barrier repair studies: comparison of Erbium:YAG laser and the suction blister method. Lasers Surg Med. 2012 Sep;44(7):525-32. doi: 10.1002/lsm.22054. Epub 2012 Aug 1.
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.
Digestive Disease Center and Copenhagen Wound Healing Center, University of Copenhagen
Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Shower gel with zinc, Plain shower gel and Distilled water in people with Denuded Epidermis, run by Bispebjerg Hospital 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Apr 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidermal regeneration (time frame: Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02116725, which also lists 6 linked publications.
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 17 Apr 2014.