Zinc Gel and Epidermal Regeneration in Healthy Human Volunteers

Phase 2

• Conditions: Denuded Epidermis
• Interventions: Other: Shower gel with zinc; Other: Plain shower gel; Other: Distilled water

• Registration Number: NCT02116725
• Lead Sponsor: Bispebjerg Hospital

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 Timeline

• Study Start: 2014-03
• Status Verified: 2014-04
• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-15
• Last Update Submitted: 2014-04-15
• Study First Posted: 2014-04-17
• Last Update Posted: 2014-04-17
• Primary Completion: 2014-06
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shower gel with zinc	Shower gel with zinc	Zinc gel is applied daily (50 µl/cm2) to wound and surrounding noninjured skin.
Plain shower gel	Plain shower gel	Plain shower gel is applied daily (50 µl/cm2) to wound and surrounding noninjured skin.
Distilled water	Distilled water	Distilled Water is applied daily (50 µl/cm2) to wound and surrounding noninjured skin.

Primary Outcome Measures

Name	Time	Method
Epidermal regeneration	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 Outcome Measures

Name	Time	Method
Keratinocyte proliferation	Day 4	Immunohistochemical detection of Ki67 in paraffin sections of the wounds using mouse monoclonal antibody (MIB-1).
Bacterial growth	Day 4	Swabs are taken from wounds and adjacent, treated skin.
Skin barrier function	Day 4	Skin barrier function is measured by transepidermal water loss by an instrument from Cortex.
Matrix metalloproteinase (MMP)-1 expression	Day 4	Immunohistochemical detection of MMP-1 in paraffin sections of the wounds using mouse monoclonal antibody.
Pain	Days 0, 1, 2, 3 and 4	Pain is assessed on a VAS scale (0-100 mm) by the participant.

Trial Locations

Locations (1)

Digestive Disease Center and Copenhagen Wound Healing Center, University of Copenhagen; 🇩🇰 Copenhagen, Denmark