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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

August 8, 2011
April 15, 2013
June 2011
July 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01413789 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Measurement and Comparison of the Occlusive and Hydrating Capacity of Three Silicone Gels and One Gel Cream
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).

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Scar Tissue or Healthy Skin
  • 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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
July 2012
July 2012   (final data collection date for primary outcome measure)

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:

-

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01413789
2011/350
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: S. Monstrey, MD PhD University Hospital, Ghent
University Hospital, Ghent
April 2013

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