Surgical ScarsCHITOSCARNCT06992960
Evaluation of the Scar Healing Effects of ChitoCare Medical Scar Healing Gel in Women Undergoing Breast Reduction or Mastopexy Surgery (CHITOSCAR)
A study testing ChitoCare® medical Scar Healing Gel (Örsáragel) and Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch in people with Surgical Scars, run by Primex ehf at 1 site in Iceland.
Trial summary
Patients undergoing breast reduction or mastopexy surgery will be screened and recruited for participation in the study. Eligible patients will act as their own control with one breast receiving the active intervention (ChitoCare® medical Scar Healing Gel) and the other receiving standard of care (Amoena CuraScar… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Scars
- What is being tested?
- ChitoCare® medical Scar Healing Gel (Örsáragel) and Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteIceland
- Study dates
- Sep 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent must be given
- Female ≥ 18 years old
- Having planned or very recently (within 21 days) undergone breast reduction or mastopexy surgery on both breasts
- Not yet begun any treatment aimed at reducing scarring
- Wound is not infected at the time of enrolment
- Able to understand and comply with the requirements of the study
Who cannot join
- Patients with serious concomitant disease (cancer, heart failure (NYHA class IV), severe anaemia (Hb<100 g/L), neoplasia)
- Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness)
- Patients who will require additional surgical procedures during the study
- Patients diagnosed with autoimmune connective tissue diseases
- Previous treatment under this clinical protocol
- Participation in another clinical trial
Show all 11Show fewer
- Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, is known to interfere with, or affect the rate and quality of wound healing
- Allergy to shellfish* (if unknown, the patient may try a small sample of the IP on their intact skin to assess for any potential allergic reaction.)
- Medical condition likely to require systemic corticosteroids during the study period
- Pregnant or lactating women
- Smoker
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iceland1 site
Klíníkin Ármúla
Reykjavik, Capital Region, 108
Craig Fraser, craig@chitocare.com
About this study
Official title: A Prospective, Randomised, Split-Body, Controlled, Non-Inferiority Clinical Study on the Scar Healing Effects of ChitoCare Medical Scar Healing Gel in Women Undergoing Breast Reduction or Mastopexy Surgery (CHITOSCAR)
Patients undergoing breast reduction or mastopexy surgery will be screened and recruited for participation in the study. Eligible patients will act as their own control with one breast receiving the active intervention (ChitoCare® medical Scar Healing Gel) and the other receiving standard of care (Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch). The active and control interventions will be applied for six months, and participants will be followed for up to 12 months. The scar properties of each breast will be assessed at study initiation (Day 0) and at study visits at 3, 6, 9, and 12 months using the Patient and Observer Scar Assessment Scale (POSAS) and via blinded assessment of photographs. Other subjective parameters such as pain, itching, and overall perception of the healed wound will be collected at each study visit via the POSAS, and patients' opinion, preferences, and compliance regarding the treatments will be collected via a basic questionnaire.
- Conditions
- Surgical Scars
- Being tested
- ChitoCare® medical Scar Healing Gel (Örsáragel), Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChitoCare® medical Scar Healing Gel (Örsáragel)Device
ChitoCare® medical Scar Healing Gel is a topical gel indicated for the treatment of new and old scars. The Scar Healing Gel provides a soothing effect and support to the scar tissue to heal in an orderly manner. It protects against infections, stimulates cell proliferation in old and new scars, as well as correct tissue organization with proper collagen alignment for a better aesthetic appearance and skin flexibility. Ideal for treating scars after accidents, surgery, C-section and cosmetic surgery. For smoother and less visible scars. May be used by the whole population, also elderly and children.
Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar PatchDevice
Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch are silicon-based, single-patient, multi-use scar patches intended for use as scar reduction therapy in surgical breast scars. The silicone creates a moist environment on the scar, which prevents the scar from drying out. It keeps the scar soft and has a positive effect on scar tissue. The devices are specifically designed for breast scarring and are shaped to fit the normal surgical scars experienced after breast surgery.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | ChitoCare® medical Scar Healing Gel (Örsáragel) administered topically twice daily for 6 months post-surgery Receives: Device: ChitoCare® medical Scar Healing Gel (Örsáragel) |
| Control | Active comparator | Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch worn daily (continuous use, minimum 12 hrs per day as per the IFU) for 6 months post-surgery Receives: Device: Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of scar assessment at 12 months
Comparison of the subjective assessment of scar appearance using the Patient and Observer Scar Assessment Scale 3.0 (POSAS) in active vs control group at 12-months post-surgery.
The POSAS 3.0, for both the Patient Scale and the Observer Scale, rates each individual item on a 5-point scale.
The minimum value for an item is 1, which corresponds to a scar characteristic or sensation that is like normal skin (a better outcome). The maximum value for an item is 5, which indicates the largest difference from normal skin or the worst imaginable scar characteristic or sensation (a worse outcome).
The total score for the Patient Scale and the Observer Scale is calculated by summing the scores of the individual items within each scale. Consequently, for the POSAS 3.0, a higher total score on either the Patient Scale or the Observer Scale signifies a worse scar outcome or a greater severity of scar-related issues from that perspective.
Measured: 12 months post-surgery
Secondary outcomes (8)
Comparison of scar assessment at 3, 6, and 9 months
Comparison of the subjective assessment of scar appearance using the Patient and Observer Scar Assessment Scale (POSAS) in active vs control group at 3, 6, and 9 months post-surgery.
The POSAS 3.0, for both the Patient Scale and the Observer Scale, rates each individual item on a 5-point scale.
The minimum value for an item is 1, which corresponds to a scar characteristic or sensation that is like normal skin (a better outcome). The maximum value for an item is 5, which indicates the largest difference from normal skin or the worst imaginable scar characteristic or sensation (a worse outcome).
The total score for the Patient Scale and the Observer Scale is calculated by summing the scores of the individual items within each scale. Consequently, for the POSAS 3.0, a higher total score on either the Patient Scale or the Observer Scale signifies a worse scar outcome or a greater severity of scar-related issues from that perspective.
Measured: 3, 6, and 9 months post-surgery
Improvement in subjective assessment of scar tissue
Improvement of the subjective assessment of scar tissue between Day 0 and 3, 6, 9, and 12 months using the POSAS in active vs control arm.
The POSAS 3.0, for both the Patient Scale and the Observer Scale, rates each individual item on a 5-point scale.
The minimum value for an item is 1, which corresponds to a scar characteristic or sensation that is like normal skin (a better outcome). The maximum value for an item is 5, which indicates the largest difference from normal skin or the worst imaginable scar characteristic or sensation (a worse outcome).
The total score for the Patient Scale and the Observer Scale is calculated by summing the scores of the individual items within each scale. Consequently, for the POSAS 3.0, a higher total score on either the Patient Scale or the Observer Scale signifies a worse scar outcome or a greater severity of scar-related issues from that perspective.
Measured: 3, 6, 9, and 12 months post-surgery
Blinded assessment of scars
Comparison of scar appearance at 3, 6, 9, and 12 months as judged by blinded assessment of photographs of active vs control intervention using the modified Stony Brook Scar Evaluation Scale (mSBSES).
For the modified SBSES, the scoring is structured such that higher scores indicate a better cosmetic outcome or less noticeable scarring. Scar width, height, colour, and presence of incision line are rated on a scale for 0-2, where 0 indicates a worse outcome, and 2 indicates similarity to normal skin. The best possible score is therefore 8, and worst outcome is 0.
Measured: 3, 6, 9, and 12 months post-surgery
Comparison of pain, discomfort, itching, and range of motion
Comparison of pain or discomfort, itching, range of motion etc. between the groups as captured by the POSAS at 3, 6, 9, and 12 months.
The POSAS 3.0, for both the Patient Scale and the Observer Scale, rates each individual item on a 5-point scale.
The minimum value for an item is 1, which corresponds to a scar characteristic or sensation that is like normal skin (a better outcome). The maximum value for an item is 5, which indicates the largest difference from normal skin or the worst imaginable scar characteristic or sensation (a worse outcome).
The total score for the Patient Scale and the Observer Scale is calculated by summing the scores of the individual items within each scale. Consequently, for the POSAS 3.0, a higher total score on either the Patient Scale or the Observer Scale signifies a worse scar outcome or a greater severity of scar-related issues from that perspective.
Measured: 3, 6, 9, and 12 months post-surgery
Adverse events
Incidence of adverse events between arms
Measured: 12 months post-surgery
Comparison of treatment compliance
Participants will be asked at 3 months and 6 months post-surgery how they would rate their compliance to each treatment (arm) via a basic questionnaire: a 5-point rating system will ask whether participants used/wore their treatment every day as recommended, most days but not always, only sometimes, rarely, or hardly ever/did no comply to treatment. Scores between the 2 arms will be compared for trends for treatment compliance.
Measured: 6 months post-surgery
Cost comparison of treatments
Cost of active vs control treatment in relation to outcomes over 6 months
Measured: 6 months post-surgery
Patient treatment preference
Participants will be asked which treatment they preferred (i.e., active vs control treatment) via a questionnaire at 3 and 6 months
Measured: 3 and 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study startSep 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Primex ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992960
- Sponsor's protocol ID
- CHITOSCAR-25-01
- Acronym
- CHITOSCAR
- Status last verified
- Aug 2025
- First submitted
- 13 May 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Split-Body, Controlled, Non-Inferiority Clinical Study on the Scar Healing Effects of ChitoCare Medical Scar Healing Gel in Women Undergoing Breast Reduction or Mastopexy Surgery (CHITOSCAR)
- ClinicalTrials.gov ID
- NCT06992960
- Acronym / sponsor ID
- CHITOSCAR / CHITOSCAR-25-01
- Conditions
- Surgical Scars
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Primex ehfIndustry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing breast reduction or mastopexy surgery will be screened and recruited for participation in the study. Eligible patients will act as their own control with one breast receiving the active intervention (ChitoCare® medical Scar Healing Gel) and the other receiving standard of care (Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch). The active and control interventions will be applied for six months, and participants will be followed for up to 12 months. The scar properties of each breast will be assessed at study initiation (Day 0) and at study visits at 3, 6, 9, and 12 months using the Patient and Observer Scar Assessment Scale (POSAS) and via blinded assessment of photographs. Other subjective parameters such as pain, itching, and overall perception of the healed wound will be collected at each study visit via the POSAS, and patients' opinion, preferences, and compliance regarding the treatments will be collected via a basic questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: ChitoCare® medical Scar Healing Gel (Örsáragel)ChitoCare® medical Scar Healing Gel (Örsáragel) administered topically twice daily for 6 months post-surgery |
| Control | Active comparator | Device: Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar PatchAmoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch worn daily (continuous use, minimum 12 hrs per day as per the IFU) for 6 months post-surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent must be given
- Female ≥ 18 years old
- Having planned or very recently (within 21 days) undergone breast reduction or mastopexy surgery on both breasts
- Not yet begun any treatment aimed at reducing scarring
- Wound is not infected at the time of enrolment
Key exclusion criteria (11 listed)
- Patients with serious concomitant disease (cancer, heart failure (NYHA class IV), severe anaemia (Hb<100 g/L), neoplasia)
- Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness)
- Patients who will require additional surgical procedures during the study
- Patients diagnosed with autoimmune connective tissue diseases
- Previous treatment under this clinical protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChitoCare® medical Scar Healing Gel (Örsáragel)ChitoCare® medical Scar Healing Gel is a topical gel indicated for the treatment of new and old scars. The Scar Healing Gel provides a soothing effect and support to the scar tissue to heal in an orderly manner. It protects against infections, stimulates cell proliferation in old and new scars, as well as correct tissue organization with proper collagen alignment for a better aesthetic appearance and skin flexibility. Ideal for treating scars after accidents, surgery, C-section and cosmetic surgery. For smoother and less visible scars. May be used by the whole population, also elderly and children. | Device | Active |
| Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar PatchAmoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch are silicon-based, single-patient, multi-use scar patches intended for use as scar reduction therapy in surgical breast scars. The silicone creates a moist environment on the scar, which prevents the scar from drying out. It keeps the scar soft and has a positive effect on scar tissue. The devices are specifically designed for breast scarring and are shaped to fit the normal surgical scars experienced after breast surgery. | Device | Control |
Primary outcome
Comparison of scar assessment at 12 months
Time frame: 12 months post-surgery
Comparison of the subjective assessment of scar appearance using the Patient and Observer Scar Assessment Scale 3.0 (POSAS) in active vs control group at 12-months post-surgery. The POSAS 3.0, for both the Patient Scale and the Observer Scale, rates each individual item on a 5-point scale. The minimum value for an item is 1, which corresponds to a scar characteristic or sensation that is like normal skin (a better outcome). The maximum value for an item is 5, which indicates the largest difference from normal skin or the worst imaginable scar characteristic or sensation (a worse outcome). The total score for the Patient Scale and the Observer Scale is calculated by summing the scores of the individual items within each scale. Consequently, for the POSAS 3.0, a higher total score on either the Patient Scale or the Observer Scale signifies a worse scar outcome or a greater severity of scar-related issues from that perspective.
8 secondary outcomes
Comparison of scar assessment at 3, 6, and 9 months
Time frame: 3, 6, and 9 months post-surgery
Improvement in subjective assessment of scar tissue
Time frame: 3, 6, 9, and 12 months post-surgery
Blinded assessment of scars
Time frame: 3, 6, 9, and 12 months post-surgery
Comparison of pain, discomfort, itching, and range of motion
Time frame: 3, 6, 9, and 12 months post-surgery
Adverse events
Time frame: 12 months post-surgery
Comparison of treatment compliance
Time frame: 6 months post-surgery
Cost comparison of treatments
Time frame: 6 months post-surgery
Patient treatment preference
Time frame: 3 and 6 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ChitoCare® medical Scar Healing Gel (Örsáragel) and Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch in people with Surgical Scars, run by Primex ehf at 1 site in Iceland.
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 6 inclusion and 11 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: opening soon, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Craig Fraser, PhD, MChem (+3548461912, craig@chitocare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of scar assessment at 12 months (time frame: 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2025.