Status:
COMPLETED
Gellan Contact Study
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
Wellcome Trust
University Hospital Birmingham
Conditions:
Thermal Injury
Skin Burn
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this study will be to establish the safety of the two different Gellan formulations (sheet and fluid gel) following its application to the epidermis of healthy volunteers. Thi...
Detailed Description
This contact study is part of the Wellcome trust Anti-scarring Dressing project to develop a carrier dressing that will be used to deliver therapeutic agents to the skin. A polysaccharide, Gellan, has...
Eligibility Criteria
Inclusion
- Male or female subjects aged ≥ 18 years old
- Subjects who can provide informed consent
Exclusion
- Subject with existing skin conditions/diseases which may interfere with the aim(s) of the study. Examples include pathological fibrosis e.g. scleroderma; pathological thinning e.g. epidermolysis bullosa and collagen disorders e.g. Marfan's syndrome
- Chronic steroid use, history of skin malignancy or chronic papulo-squamous disease (e.g. eczema, pemphigus) and history of Steven Johnson or TENS disease
- Blemishes, marks (e.g. tattoos, scars or burns,) on the test site(s) which may interfere with assessment on the test site
- Use of medication which may affect may affect skin response
- Known allergy to the materials used in the study
- Known allergy to adhesive plasters or tapes
- Fitzpatrick skin type VI (due to the difficulty of identifying erythema)
- Irritated skin on the test site
- Known pregnancy (confirmed by urine pregnancy test) or lactating
- Inability to commit to attending all sessions.
- Participation in another study which may affect the results of this contact study.
- Any other reason that clinician considers will interfere with the objectives of the study
Key Trial Info
Start Date :
October 10 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04044014
Start Date
October 10 2016
End Date
August 1 2017
Last Update
August 2 2019
Active Locations (1)
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1
Wellcome Trust Clinical Research Facility
Birmingham, West Midlands, United Kingdom, B15 2TH