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

Study Overview
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Brief Summary
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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).

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

Conditions
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Scar Tissue or Healthy Skin

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 hour after application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 hours after application | 
| 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. | 3 hours after application |