Clinical trial NCT02116725: Zinc Gel and Epidermal Regeneration in Healthy Human Volunteers
Official title: Effects of Shower Gel With Zinc on Epidermal Regeneration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Denuded Epidermis
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2014-04-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Epidermal regeneration
timeFrame: Day 4
Secondary outcomes:
measure: Bacterial growth
timeFrame: Day 4
measure: Skin barrier function
timeFrame: Day 4
measure: Keratinocyte proliferation
timeFrame: Day 4
measure: Matrix metalloproteinase (MMP)-1 expression
timeFrame: Day 4
measure: Pain
timeFrame: Days 0, 1, 2, 3 and 4
Other outcomes:
measure: Serum zinc
timeFrame: Day 0
measure: Zinc deposition onto skin
timeFrame: Day 4
Locations:
city: Copenhagen
country: Denmark
facility: Digestive Disease Center and Copenhagen Wound Healing Center, University of Copenhagen
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.