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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT01413789

First received: August 8, 2011

Last updated: April 15, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 8, 2011

Last Updated Date

April 15, 2013

Start Date ^ICMJE

June 2011

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The occlusive and hydrating capacity of the products. [ Time Frame: 1 hour after application ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01413789 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The occlusive and hydrating capacity of the products. [ Time Frame: 2 hours after application ] [ Designated as safety issue: No ]
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. [ Time Frame: 3 hours after application ] [ Designated as safety issue: No ]
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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Scar Tissue or Healthy Skin

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Patients and healthy volunteers

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

Interventions:

Drug: Dermatix
Drug: Kelocote
Drug: BAP scar gel
Drug: Alhydran
Drug: Bap Scar Care T
Drug: Bap Scar Care S
Drug: Mepiform
Drug: Scar Ban Elastic

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2012

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01413789

Other Study ID Numbers ^ICMJE

2011/350

Has Data Monitoring Committee

Responsible Party

University Hospital, Ghent

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

S. Monstrey, MD PhD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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