Zinc Gel and Epidermal Regeneration in Healthy Human Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Denuded Epidermis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Shower gel with zinc

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

Group Type EXPERIMENTAL

Shower gel with zinc

Intervention Type OTHER

Standard shower gel (Sanex) supplemented with zinc sulfate.

Plain shower gel

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

Group Type PLACEBO_COMPARATOR

Plain shower gel

Intervention Type OTHER

Standard shower gel (Sanex).

Distilled water

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

Group Type SHAM_COMPARATOR

Distilled water

Intervention Type OTHER

Sterile distilled Water.

Interventions

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Shower gel with zinc

Standard shower gel (Sanex) supplemented with zinc sulfate.

Intervention Type OTHER

Plain shower gel

Standard shower gel (Sanex).

Intervention Type OTHER

Distilled water

Sterile distilled Water.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes