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

Primary Purpose

Scar Tissue or Healthy Skin

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Dermatix
Kelocote
BAP scar gel
Alhydran
Bap Scar Care T
Bap Scar Care S
Mepiform
Scar Ban Elastic
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scar Tissue or Healthy Skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients and healthy volunteers

Arm Description

Patients with healed full thickness burns and healthy volunteers will be included in the study

Outcomes

Primary Outcome Measures

The occlusive and hydrating capacity of the products.
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.

Secondary Outcome Measures

The occlusive and hydrating capacity of the products.
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.
The occlusive and hydrating capacity of the products.
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.

Full Information

First Posted
August 8, 2011
Last Updated
April 15, 2013
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01413789
Brief Title
Measurement and Comparison of the Occlusive and Hydrating Capacity of Three Silicone Gels and One Gel Cream
Official Title
Measurement and Comparison of the Occlusive and Hydrating Capacity of Three Silicone Gels: BAP Scar Gel, Dermatix, Kelocote and One Gel- Cream: Alhydran
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar Tissue or Healthy Skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients and healthy volunteers
Arm Type
Experimental
Arm Description
Patients with healed full thickness burns and healthy volunteers will be included in the study
Intervention Type
Drug
Intervention Name(s)
Dermatix
Intervention Description
1 application of Dermatix
Intervention Type
Drug
Intervention Name(s)
Kelocote
Intervention Description
1 application of Kelocote
Intervention Type
Drug
Intervention Name(s)
BAP scar gel
Intervention Description
1 application of BAP scar gel
Intervention Type
Drug
Intervention Name(s)
Alhydran
Intervention Description
1 application of Alhydran
Intervention Type
Drug
Intervention Name(s)
Bap Scar Care T
Intervention Description
1 application of BAP Scar Care T
Intervention Type
Drug
Intervention Name(s)
Bap Scar Care S
Intervention Description
1 Application of Bap Scar Care S
Intervention Type
Drug
Intervention Name(s)
Mepiform
Intervention Description
1 application of Mepiform
Intervention Type
Drug
Intervention Name(s)
Scar Ban Elastic
Intervention Description
1 application of Scar Ban Elastic
Primary Outcome Measure Information:
Title
The occlusive and hydrating capacity of the products.
Description
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.
Time Frame
1 hour after application
Secondary Outcome Measure Information:
Title
The occlusive and hydrating capacity of the products.
Description
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.
Time Frame
2 hours after application
Title
The occlusive and hydrating capacity of the products.
Description
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.
Time Frame
3 hours after application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S. Monstrey, MD PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Related Info

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

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