Scar Tissue or Healthy SkinNCT01413789
Measurement and Comparison of the Occlusive and Hydrating Capacity of Three Silicone Gels and One Gel Cream
A study testing Dermatix, Kelocote and BAP scar gel in people with Scar Tissue or Healthy Skin, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scar Tissue or Healthy Skin
- What is being tested?
- Dermatix, Kelocote and BAP scar gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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 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.
Read more
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).
- Conditions
- Scar Tissue or Healthy Skin
- Being tested
- Dermatix, Kelocote, BAP scar gel, Alhydran, Bap Scar Care T
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermatixDrug
1 application of Dermatix
KelocoteDrug
1 application of Kelocote
BAP scar gelDrug
1 application of BAP scar gel
AlhydranDrug
1 application of Alhydran
Bap Scar Care TDrug
1 application of BAP Scar Care T
Bap Scar Care SDrug
1 Application of Bap Scar Care S
MepiformDrug
1 application of Mepiform
Scar Ban ElasticDrug
1 application of Scar Ban Elastic
| Study group | Role | What they receive |
|---|---|---|
| Patients and healthy volunteers | Experimental | Patients with healed full thickness burns and healthy volunteers will be included in the study Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour after application
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3 hours after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scar Tissue or Healthy SkinStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- S. Monstrey, MD PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413789
- Sponsor's protocol ID
- 2011/350
- Status last verified
- Apr 2013
- First submitted
- 8 Aug 2011
- Last updated
- 16 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01413789
- Acronym / sponsor ID
- 2011/350
- Conditions
- Scar Tissue or Healthy Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients and healthy volunteers | Experimental | 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 ElasticPatients with healed full thickness burns and healthy volunteers will be included in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermatix1 application of Dermatix | Drug | Patients and healthy volunteers |
| Kelocote1 application of Kelocote | Drug | Patients and healthy volunteers |
| BAP scar gel1 application of BAP scar gel | Drug | Patients and healthy volunteers |
| Alhydran1 application of Alhydran | Drug | Patients and healthy volunteers |
| Bap Scar Care T1 application of BAP Scar Care T | Drug | Patients and healthy volunteers |
| Bap Scar Care S1 Application of Bap Scar Care S | Drug | Patients and healthy volunteers |
| Mepiform1 application of Mepiform | Drug | Patients and healthy volunteers |
| Scar Ban Elastic1 application of Scar Ban Elastic | Drug | Patients and healthy volunteers |
Primary outcome
The occlusive and hydrating capacity of the products.
Time frame: 1 hour after application
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 secondary outcomes
The occlusive and hydrating capacity of the products.
Time frame: 2 hours after application
The occlusive and hydrating capacity of the products.
Time frame: 3 hours after application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S. Monstrey, MD PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermatix, Kelocote and BAP scar gel in people with Scar Tissue or Healthy Skin, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occlusive and hydrating capacity of the products. (time frame: 1 hour after application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2013.