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CicatrixNCT05412745

Class I Medical Device on Post-surgical Scars

A study testing Kaloidon Plus and silicone gel in people with Cicatrix and Post-Surgical Complication, run by University of Rome Tor Vergata at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cicatrix, Post-Surgical Complication, Scar Itching
What is being tested?
Kaloidon Plus and silicone gel
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
2 sitesItaly
Study dates
1 May 2022to 10 Sep 2022
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Elena Campione

    Roma, 00133

  • Tor Vergata Univerisity Hospital

    Rome, 00133

Other trials in Italy

About this study

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

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

Read the detailed description

A head-to-head, randomised, pivotal controlled trial evaluating the appearance of post-surgical scars for 12 weeks. The study was developed in 10 months, including recruitment, evaluation every 4 weeks and evaluation of the secondary objective in the third month (T2). The primary endpoint was the evaluation of the effectiveness of the class I medical device contain onion (Allium cepa) extract compared to the silicone gel used in the treatment of post-surgical scars for the prevention of hypertrophic scars. Objective scar assessment using the Vancouver Scar Scale (VSS), Manchester Scale, Patient and Observer Scar Assessment Scale (POSAS), itching, redness and pliability were performed after 4,8 and 12 weeks of treatment. Safety was also evaluated by gathering adverse events related to application of the gel. The statistical analysis of the data was carried out by applying parametric or non-parametric tests depending on the distribution of the data that was going to be obtained. The one-way analysis of variance ANOVA test was used to evaluate the reduction/increase of clinical parameters in the pre-established observation times (T0, T2, T3 and T4) for each treatment, whereas comparison between treatments was performed via t-test analysis. Correlation tests were also used. The differences were considered statistically significant for p values <0.05.

Being tested
Kaloidon Plus, silicone gel
Keywords
scar, Keloid, Cicatrix, allium cepa, silicone
Medical subject headings
Cicatrix, Keloid, Cicatrix, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kaloidon PlusDevice

    topical application; twice daily

  • silicone gelDevice

    topical application; twice daily

Study groups in NCT05412745
Study groupRoleWhat they receive
group AExperimentalclass I pullulan based medical device containing Allium cepa \& HA
Receives: Device: Kaloidon Plus
Group BActive comparatorclass I medical device silicone gel
Receives: Device: silicone gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: week 4,8,12

  2. 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).

    Measured: week 4,8,12

  3. 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).

    Measured: week 4,8,12

  4. 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).

    Measured: week 4,8,12

  5. 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).

    Measured: week 4,8,12

  6. 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).

    Measured: week 4,8,12

Secondary outcomes (1)

  1. 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.

    Measured: week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2022
  2. Study start1 May 2022
  3. Primary completion10 Sep 2022
  4. Study completion10 Sep 2022

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05412745
Sponsor's protocol ID
R.S. 211.19
Status last verified
Sep 2022
First submitted
25 May 2022
Last updated
14 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cosio T, Costanza G, Coniglione F, Romeo A, Iacovelli F, Diluvio L, Dika E, Shumak RG, Rossi P, Bianchi L, Falconi M, Campione E. From In Silico Simulation between TGF-beta Receptors and Quercetin to Clinical Insight of a Medical Device Containing Allium cepa: Its Efficacy and Tolerability on Post-Surgical Scars. Life (Basel). 2023 Aug 21;13(8):1781. doi: 10.3390/life13081781.

    PubMed 37629638

Questions about this trial

What is this clinical trial studying?

A study testing Kaloidon Plus and silicone gel in people with Cicatrix and Post-Surgical Complication, run by University of Rome Tor Vergata at 2 sites in Italy.

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 1 inclusion and 5 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 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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?

Change of Vancouver Scar Scale (VSS) (time frame: week 4,8,12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05412745, which also lists 1 linked publication.

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 14 Sep 2022.

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