Measurement and Comparison of the Occlusive and Hydrating Capacity of Three Silicone Gels and One Gel Cream

April 15, 2013 updated by: University Hospital, Ghent

Measurement and Comparison of the Occlusive and Hydrating Capacity of Three Silicone Gels: BAP Scar Gel, Dermatix, Kelocote and One Gel- Cream: Alhydran

Study hypothesis: Is Alhydran gel-cream as efficient as silicone gel for skin occlusion and hydration?

For this study 16 volunteers and ten patients with healed full thickness burns will be included.

After a short period of acclimatization four test areas will be determined. For healthy volunteers the standard zones are located on the inner forearm, two on each forearm.

For patients with healed burns the 4 test zones are located on either the healed donor site or the healed skin grafted area.

In each test zone baseline measurements will be taken before application of the products.After application of the three silicone gels and the hydrating gel cream the trans epidermal water loss (TEWL) and the moisture content of the stratum corneum will be measured by using the TEWAmeter®TM300 and the Corneometer® CM825 (Courage & Khazaka).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy volunteers or patients with healed full thickness burns and donor sites
  • not pregnant
  • age>18 years
  • male or female
  • written authorisation of the patient or volunteer is required.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients and healthy volunteers
Patients with healed full thickness burns and healthy volunteers will be included in the study
Drug: Dermatix
1 application of Dermatix
Drug: Kelocote
1 application of Kelocote
Drug: BAP scar gel
1 application of BAP scar gel
Drug: Alhydran
1 application of Alhydran
Drug: Bap Scar Care T
1 application of BAP Scar Care T
Drug: Bap Scar Care S
1 Application of Bap Scar Care S
Drug: Mepiform
1 application of Mepiform
Drug: Scar Ban Elastic
1 application of Scar Ban Elastic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occlusive and hydrating capacity of the products.
Time Frame: 1 hour after application
Measurements will be done by using the TEWAmeter® for measurement of the Trans Epidermal Waterloss and the Corneometer® 825CM for measurement of the moisture content of the stratum corneum (Courage & Khazaka). For this study no risk factors are determined.
1 hour after application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occlusive and hydrating capacity of the products.
Time Frame: 2 hours after application
Measurements will be done by using the TEWAmeter® for measurement of the Trans Epidermal Waterloss and the Corneometer® 825CM for measurement of the moisture content of the stratum corneum (Courage & Khazaka). For this study no risk factors are determined.
2 hours after application
The occlusive and hydrating capacity of the products.
Time Frame: 3 hours after application
Measurements will be done by using the TEWAmeter® for measurement of the Trans Epidermal Waterloss and the Corneometer® 825CM for measurement of the moisture content of the stratum corneum (Courage & Khazaka). For this study no risk factors are determined.
3 hours after application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: S. Monstrey, MD PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

August 8, 2011

First Submitted That Met QC Criteria

August 9, 2011

First Posted (Estimate)

August 10, 2011

Study Record Updates

Last Update Posted (Estimate)

April 16, 2013

Last Update Submitted That Met QC Criteria

April 15, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/350

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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