Keloid Clinical Trial
Official title:
Head-to-head, Randomized Pivotal Study to Evaluate the Effect of a Class I Pullulan Based Medical Device Containing Allium Cepa and Hyaluronic Acid Compared to Class I Medical Device Silicone Gel on Post-surgical Scars
Verified date | September 2022 |
Source | University of Rome Tor Vergata |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare the effect of a class I pullulan based medical device containing Allium cepa & HA versus a class I medical device silicone gel on new post-surgical wounds
Status | Completed |
Enrollment | 64 |
Est. completion date | September 10, 2022 |
Est. primary completion date | September 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Subjects aged between 18 and 70 who have undergone surgery for the excision of skin lesions at least 20 days before the start of the protocol. Exclusion Criteria: - Subjects affected by spontaneous keloids - Diabetic subjects with a previous history of disorders in the repair of wounds; - Subjects with overinfected wounds after the first week after surgery; - Subjects with documented sensitivity to silicone gel; - Subjects affected by collagen disorders (e.g. Pseudoxantoma elasticum, poikilodermatosis). |
Country | Name | City | State |
---|---|---|---|
Italy | Elena Campione | Roma | |
Italy | Tor Vergata Univerisity Hospital | Rome |
Lead Sponsor | Collaborator |
---|---|
University of Rome Tor Vergata |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of Vancouver Scar Scale (VSS) | Change of Vancouver Scar Scale (VSS) from baseline to weeks 4,8 and 12.
vascularity(range from normal(0 point) to purple(3point) pigmentation(range from normal(0 point) to hyper-pigmentation(3point) pliability(range from normal(0 point) to contracture(5point) height (range from flat(0 point) to above 5mm(3point) pain(range from none(0 point) to Require medication(2point) itchiness(range from none(0 point) to Require medication(2point) We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition. |
week 4,8,12 | |
Primary | Change of Manchester Scale | Change of Manchester Scale from baseline to weeks 4,8 and 12.
Color (range from perfect (1 point) to Gross mismatch (4 points) Shine ( from matte (1 point) to shiny (2 points)) Contour ( from Flush with surrounding skin (1 point) to keloid (4 points)) Distortion ( from none (1 point) to severe (4 points)) Lower score denotes a better outcome using the MSS (range: 4-14). |
week 4,8,12 | |
Primary | Change of Patient and Observer Scar Assessment Scale (POSAS) from baseline to weeks 4,8 and 12. | Change of Patient and Observer Scar Assessment Scale (POSAS) from baseline to weeks 4,8 and 12. Lower score denotes a better outcome using the POSAS (range: 0-10). | week 4,8,12 | |
Primary | Change of itching from baseline to weeks 4,8 and 12 | Change of itching from baseline to weeks 4,8 and 12 will be measure with the visual analogue scale (VAS). Lower score denotes a better outcome using the VAS (range: 0-10). | week 4,8,12 | |
Primary | Change of redness from baseline to weeks 4,8 and 12 | Change of redness from baseline to weeks 4,8 and 12 will be evaluted as 10 points scale, from normal (1 point) to purple (10 points). Lower score denotes a better outcome (range: 0-10). | week 4,8,12 | |
Primary | Change of pliability from baseline to weeks 4,8 and 12 | Change of pliability from baseline to weeks 4,8 and 12 will be measured by testing folding of the scar with a six-step scale: normal, supple, yielding, firm, banding, and contracture. Lower score denotes a better outcome (range: 0-10). | week 4,8,12 | |
Secondary | Incidence of adverse events occurrence after treatment | Incidence of adverse events will be evaluated since the baseline visit until 12 weeks after the end of the treatment. Adverse Events reported by patients or noticed by investigator will be reported as local skin reactions. | week 12 |
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