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Zinc Gel and Epidermal Regeneration in Healthy Human Volunteers

Effects of Shower Gel With Zinc on Epidermal Regeneration

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02116725
Acronym
ZINGEL
Enrollment
30
Registered
2014-04-17
Start date
2014-03-31
Completion date
2014-09-30
Last updated
2014-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Denuded Epidermis

Brief 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.

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.

Interventions

OTHERShower gel with zinc

Standard shower gel (Sanex) supplemented with zinc sulfate.

OTHERPlain shower gel

Standard shower gel (Sanex).

OTHERDistilled water

Sterile distilled Water.

Sponsors

Bispebjerg Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy male and female volunteers * Age between18 and 65 years * Written informed consent

Exclusion criteria

* Smoker * Active skin disease in test areas * Hypersensitivity to zinc or any of the shower gel ingredients * Immunosuppressive treatment * Pregnant or breastfeeding females

Design outcomes

Primary

MeasureTime frameDescription
Epidermal regenerationDay 4Epidermal regeneration will be assessed blindly by histomorphometry in hematoxylin-eosin-stained paraffin sections of the wounds and by optical coherence tomography.

Secondary

MeasureTime frameDescription
Bacterial growthDay 4Swabs are taken from wounds and adjacent, treated skin.
Skin barrier functionDay 4Skin barrier function is measured by transepidermal water loss by an instrument from Cortex.
Keratinocyte proliferationDay 4Immunohistochemical detection of Ki67 in paraffin sections of the wounds using mouse monoclonal antibody (MIB-1).
Matrix metalloproteinase (MMP)-1 expressionDay 4Immunohistochemical detection of MMP-1 in paraffin sections of the wounds using mouse monoclonal antibody.
PainDays 0, 1, 2, 3 and 4Pain is assessed on a VAS scale (0-100 mm) by the participant.

Other

MeasureTime frameDescription
Serum zincDay 0
Zinc deposition onto skinDay 4Stratum corneum will be removed by adhesive tape (tape-stripping) for zinc analysis.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026