Effects of Shower Gel With Zinc on Epidermal Regeneration
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Bispebjerg Hospital
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Epidermal regeneration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male and female volunteers
- •Age between18 and 65 years
- •Written informed consent
Exclusion Criteria
- •Active skin disease in test areas
- •Hypersensitivity to zinc or any of the shower gel ingredients
- •Immunosuppressive treatment
- •Pregnant or breastfeeding females
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Bacterial growth(Day 4)
- Skin barrier function(Day 4)
- Keratinocyte proliferation(Day 4)
- Matrix metalloproteinase (MMP)-1 expression(Day 4)
- Pain(Days 0, 1, 2, 3 and 4)
Investigators
Lars Nannestad Jorgensen
Professor
Bispebjerg Hospital