Scar Tissue or Healthy Skin Clinical Trial
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
| Verified date | April 2013 |
| Source | University Hospital, Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Ethics Committee |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 55 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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: |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital | Ghent |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Ghent |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |