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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01413789

Enrollment

Registered

2011-08-10

Start date

2011-06-30

Completion date

2012-07-31

Last updated

2013-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scar Tissue or Healthy Skin

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).

Interventions

DRUGDermatix

1 application of Dermatix

DRUGKelocote

1 application of Kelocote

DRUGBAP scar gel

1 application of BAP scar gel

DRUGAlhydran

1 application of Alhydran

DRUGBap Scar Care T

1 application of BAP Scar Care T

DRUGBap Scar Care S

1 Application of Bap Scar Care S

DRUGMepiform

1 application of Mepiform

DRUGScar Ban Elastic

1 application of Scar Ban Elastic

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
The occlusive and hydrating capacity of the products.	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.

Secondary

Measure	Time frame	Description
The occlusive and hydrating capacity of the products.	2 hours 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026