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

Bispebjerg Hospital

Status and phase: Unknown; Phase 2

Conditions: Denuded Epidermis

Treatments: Other: Shower gel with zinc; Other: Plain shower gel; Other: Distilled water

Study type: Interventional

Funder types: Other

Identifiers

NCT02116725

ERS-2013-01-LDT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

Shower gel with zinc

Experimental group

Description:

Zinc gel is applied daily (50 µl/cm2) to wound and surrounding noninjured skin.

Treatment:

Other: Shower gel with zinc

Plain shower gel

Placebo Comparator group

Description:

Plain shower gel is applied daily (50 µl/cm2) to wound and surrounding noninjured skin.

Treatment:

Other: Plain shower gel

Distilled water

Sham Comparator group

Description:

Distilled Water is applied daily (50 µl/cm2) to wound and surrounding noninjured skin.

Treatment:

Other: Distilled water