Zinc Gel and Epidermal Regeneration in Healthy Human Volunteers (ZINGEL)

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.

Study Overview

• Status: Unknown
• Conditions: Denuded Epidermis
• Intervention / Treatment: Other: Shower gel with zinc; Other: Plain shower gel; Other: Distilled water

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, DK-2400
    • Recruiting
    • Digestive Disease Center and Copenhagen Wound Healing Center, University of Copenhagen
    • Contact: Heidi F Larsen, MD; Phone Number: (+45) 35313531
    • Principal Investigator: Lars N Jørgensen, MD, DMSc
    • Sub-Investigator: Magnus S Ågren, DMSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shower gel with zinc; Zinc gel is applied daily (50 µl/cm2) to wound and surrounding noninjured skin.	Other: Shower gel with zinc; Standard shower gel (Sanex) supplemented with zinc sulfate.
Placebo Comparator: Plain shower gel; Plain shower gel is applied daily (50 µl/cm2) to wound and surrounding noninjured skin.	Other: Plain shower gel; Standard shower gel (Sanex).
Sham Comparator: Distilled water; Distilled Water is applied daily (50 µl/cm2) to wound and surrounding noninjured skin.	Other: Distilled water; Sterile distilled Water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidermal regeneration	Epidermal regeneration will be assessed blindly by histomorphometry in hematoxylin-eosin-stained paraffin sections of the wounds and by optical coherence tomography.	Day 4

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum zinc		Day 0
Zinc deposition onto skin	Stratum corneum will be removed by adhesive tape (tape-stripping) for zinc analysis.	Day 4

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital

Publications and helpful links

General 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.
• Woodley 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.
• Agren 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.
• Malminen 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.
• Agren 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.
• Ferraq 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: April 15, 2014
• First Posted (Estimate): April 17, 2014

Study Record Updates

• Last Update Posted (Estimate): April 17, 2014
• Last Update Submitted That Met QC Criteria: April 15, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: ERS-2013-01-LDT