Clinical trial NCT04044014: Gellan Contact Study
Official title: Prospective, Randomized Control Trial to Evaluate the Dermatological Reaction of Healthy Volunteers to Gellan Sheet and Fluid Gel Dressings (Gellan Contact Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thermal Injury
Skin Burn
Keywords: Gellan, thermal injury, healthy volunteers, skin
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: University Hospital Birmingham
First posted: 2019-08-02
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised to receive the treatment dressing (either the Gellan sheet or Gellan fluid gel) on one arm (Left or Right), and the control dressing (Mepitel One) on the other arm. The first phase will be for 1 hour and the 2nd phase will be for 3 days.
Primary purpose: OTHER

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. This will be compared to a control dressing-- Mepitel One (Polyurethane net with soft Silicone).

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 been chosen as the main component of this dressing (the biomembrane)and it can be produced in either a sheet or fluid gel forms. Gellan is a widely used material in both the food and medical industry e.g. as a lubricant in eye-drops (e.g. Timoptol XE, Merck Sharp \& Dohme, USA).

As part of the development of the dressing, the epidermal (skin) response to Gellan needs to be evaluated to check its safety.

The main objective of this study is to establish the safety of the two different Gellan formulations (2% Gellan sheet and 2% Gellan fluid gel) following application to the epidermis (skin).

Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged ≥ 18 years old
* Subjects who can provide informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Skin reaction
timeFrame: 3 days (72 hours+/-3 hours)
Secondary outcomes:
measure: Participant satisfaction with dressing
timeFrame: At end of study (after 3 days)
measure: Clinician satisfaction with dressing
timeFrame: At end of study (after 3 days)
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Wellcome Trust Clinical Research Facility
state: West Midlands
Study officials:
References: