NCT02116725

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

3 months

First QC Date

April 15, 2014

Last Update Submit

April 15, 2014

Conditions

Denuded Epidermis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Bacterial growth

    Day 4

  • Skin barrier function

    Day 4

  • Keratinocyte proliferation

    Day 4

  • Matrix metalloproteinase (MMP)-1 expression

    Day 4

  • Pain

    Days 0, 1, 2, 3 and 4

Other Outcomes (2)

  • Serum zinc

    Day 0

  • Zinc deposition onto skin

    Day 4

Study Arms (3)

Shower gel with zinc

EXPERIMENTAL

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

Other: Shower gel with zinc

Plain shower gel

PLACEBO COMPARATOR

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

Other: Plain shower gel

Distilled water

SHAM COMPARATOR

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

Other: Distilled water

Interventions

Shower gel with zincOTHER

Standard shower gel (Sanex) supplemented with zinc sulfate.

Shower gel with zinc
Plain shower gelOTHER

Standard shower gel (Sanex).

Plain shower gel
Distilled waterOTHER

Sterile distilled Water.

Distilled water

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male and female volunteers
  • Age between18 and 65 years
  • Written informed consent

You may not qualify if:

  • Smoker
  • Active skin disease in test areas
  • Hypersensitivity to zinc or any of the shower gel ingredients
  • Immunosuppressive treatment
  • Pregnant or breastfeeding females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Digestive Disease Center and Copenhagen Wound Healing Center, University of Copenhagen

Copenhagen, DK-2400, Denmark

RECRUITING

Related Publications (6)

  • 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.

    PMID: 17244314BACKGROUND

  • 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.

    PMID: 1417023BACKGROUND

  • 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.

    PMID: 11589731BACKGROUND

  • 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.

    PMID: 12932229BACKGROUND

  • 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.

    PMID: 1990212BACKGROUND

  • 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.

    PMID: 22865469BACKGROUND

MeSH Terms

Interventions

Zinc

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 17, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations

DK(1)