Hypertrophic ScarsNCT07269093
Efficacy in Preventing Hypertrophic Scars: A Randomised Controlled Trial Comparing Chitosan Cream, Silicone Gel & Olive Oil
A study testing Chitosan cream, Silicone Gel and Olive Oil Topical Oil in people with Hypertrophic Scars, run by Universiti Sains Malaysia at 3 sites in Malaysia.
Trial summary
The goal of this clinical trial is to compare the efficacy of three different topical applications in preventing hypertrophic scars in adults with scars healed after suturing. The main question it aims to answer is: Is Chitosan cream effective in preventing hypertrophic scars? Researchers will compare Chitosan cream… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertrophic Scars
- What is being tested?
- Chitosan cream, Silicone Gel and Olive Oil Topical Oil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesMalaysia
- Study dates
- 21 Dec 2025to Nov 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with traumatic or surgical wounds which have healed by primary intention within 14 days
- Length of scar at least 3cm
Who cannot join
- Patients with seafood allergy
- Patients with scar from wounds that were complicated by infection or wound breakdown
- Patients who have undergone scar treatment by other modalities
- Patients with history of keloids / hypertrophic scars
- Pregnant patients
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia3 sites, 3 recruiting
- Not yet recruiting
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, 15586
Aida Nadhirah Nor Azizan, MBBS
Esther HM Tan, MBBS
- Not yet recruiting
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 50586
Esther HM Tan, MBBS
- Recruiting
Hospital Pakar Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
Esther HM Tan, MBBS, +6097673000, esthertan@student.usm.my
Esther HM Tan, MBBS
About this study
The goal of this clinical trial is to compare the efficacy of three different topical applications in preventing hypertrophic scars in adults with scars healed after suturing. The main question it aims to answer is: Is Chitosan cream effective in preventing hypertrophic scars?
Researchers will compare Chitosan cream with silicone gel and olive oil to see if there is any difference in their efficacies.
Read more
Participants will be randomly assigned to three groups, with each group using a different topical application. They will be instructed to:
- apply the topical application on their scar twice a day for 8 weeks
- attend follow-up visits at 4, 12 and 24 weeks for a doctor to assess their scar and take clinical photographs
- immediately inform the researcher if they experience any side effects
Read the detailed description
This is a 3-arm single-blinded randomised controlled trial to study the efficacy of three topical applications in preventing hypertrophic scars. The general objective is to investigate the efficacy of Chitosan cream in preventing hypertrophic scars compared to other topical applications commonly used; silicone gel and olive oil. The hypothesis is that Chitosan cream shows comparable efficacy in preventing hypertrophic scars compared to silicone gel and olive oil.
The study population consists of patients who had traumatic or surgical scars that have healed by primary intention in the Unit of Reconstructive Sciences, Hospital Pakar USM, Plastic \& Reconstructive Surgery Unit of Hospital Raja Perempuan Zainab II and the Plastic \& Reconstructive Surgery Department of Hospital Kuala Lumpur and have met the study inclusion criteria.
Patients who meet the inclusion criteria will be given a topical application (Chitosan cream / silicone gel / olive oil) which is assigned randomly by computer software (SPSS version 29). The topical applications is to be applied twice daily from the 14th day since wounding. The investigator will be blinded to the topical application given to the patient. Both patient and investigator will assess the scar using Patient \& Observer Scar Assessment Scale (POSAS) version 3.0 and scars will be photographed under fixed camera settings \& lighting conditions. Patients will come for follow-up on weeks 4, 12 \& 24 and the scar assessment will be repeated by both patient \& the same observer. Serial photographs will also be taken each visit. At the end of the 24 weeks, photographs of the scars will be reviewed by three independent plastic surgeons and scored using the Scar Cosmesis \& Assessment Rating (SCAR) Scale. Both the scores from the clinical \& photographic scar assessments will be evaluated to compare the efficacy of each topical application. The duration of the study is from Nov 2025-Nov 2026.
- Conditions
- Hypertrophic Scars
- Being tested
- Chitosan cream, Silicone Gel, Olive Oil Topical Oil
- Keywords
- Chitosan, silicone gel, olive oil, hypertrophic scars, prevention
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chitosan creamDevice
Application of Chitosan cream twice daily for 8 weeks
Silicone GelDevice
Application of silicone gel twice a day for 8 weeks
Olive Oil Topical OilDevice
Application of olive oil twice daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Silicone gel | Active comparator | Silicone gel application twice a day for 8 weeks Receives: Device: Silicone Gel |
| Chitosan cream | Experimental | Chitosan cream application twice a day for 8 weeks Receives: Device: Chitosan cream |
| Olive oil | Placebo comparator | Olive oil application twice a day for 8 weeks Receives: Device: Olive Oil Topical Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and Observer Scar Assessment Scale (POSAS) scores
Each item is rated on a 5-point score. The lowest score is '1' which corresponds to the situation of normal skin. Score '5' being the largest difference from normal skin.
Measured: Enrolment to 24 weeks
Scar Assessment and Rating (SCAR) Scale scores
Scores of clinical photographs of each scar by 3 plastic surgeons. Score '0' indicates conditions closest to normal skin. Maximum scores for each item range from 1 to 4, where higher scores indicate larger differences from normal skin.
Measured: Enrolment to 24 weeks
Secondary outcomes (1)
Side effects
Patients are to report any side effects that they experience with use of any topical application. Side effects encountered are recorded.
Measured: Enrolment to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start21 Dec 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Tan Hui Min, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269093
- Sponsor's protocol ID
- USM/JEPeM/KK/25060539
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient privacy protection
Publications
Kantor J. Reliability and Photographic Equivalency of the Scar Cosmesis Assessment and Rating (SCAR) Scale, an Outcome Measure for Postoperative Scars. JAMA Dermatol. 2017 Jan 1;153(1):55-60. doi: 10.1001/jamadermatol.2016.3757.
PubMed 27806156Carriere ME, Mokkink LB, Tyack Z, Westerman MJ, Pijpe A, Pleat J, van de Kar AL, Brown J, de Vet HCW, van Zuijlen PPM. Development of the Patient Scale of the Patient and Observer Scar Assessment Scale (POSAS) 3.0: a qualitative study. Qual Life Res. 2023 Feb;32(2):583-592. doi: 10.1007/s11136-022-03244-6. Epub 2022 Nov 10.
PubMed 36355319
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy in Preventing Hypertrophic Scars: A Randomised Controlled Trial Comparing Chitosan Cream, Silicone Gel & Olive Oil
- ClinicalTrials.gov ID
- NCT07269093
- Acronym / sponsor ID
- USM/JEPeM/KK/25060539
- Conditions
- Hypertrophic Scars
- Keywords
- Chitosan, silicone gel, olive oil, hypertrophic scars, prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 21 Dec 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 8 Dec 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.
The goal of this clinical trial is to compare the efficacy of three different topical applications in preventing hypertrophic scars in adults with scars healed after suturing. The main question it aims to answer is: Is Chitosan cream effective in preventing hypertrophic scars?
Researchers will compare Chitosan cream with silicone gel and olive oil to see if there is any difference in their efficacies.
Participants will be randomly assigned to three groups, with each group using a different topical application. They will be instructed to:
- apply the topical application on their scar twice a day for 8 weeks
- attend follow-up visits at 4, 12 and 24 weeks for a doctor to assess their scar and take clinical photographs
- immediately inform the researcher if they experience any side effects
Detailed description
This is a 3-arm single-blinded randomised controlled trial to study the efficacy of three topical applications in preventing hypertrophic scars. The general objective is to investigate the efficacy of Chitosan cream in preventing hypertrophic scars compared to other topical applications commonly used; silicone gel and olive oil. The hypothesis is that Chitosan cream shows comparable efficacy in preventing hypertrophic scars compared to silicone gel and olive oil.
The study population consists of patients who had traumatic or surgical scars that have healed by primary intention in the Unit of Reconstructive Sciences, Hospital Pakar USM, Plastic \& Reconstructive Surgery Unit of Hospital Raja Perempuan Zainab II and the Plastic \& Reconstructive Surgery Department of Hospital Kuala Lumpur and have met the study inclusion criteria.
Patients who meet the inclusion criteria will be given a topical application (Chitosan cream / silicone gel / olive oil) which is assigned randomly by computer software (SPSS version 29). The topical applications is to be applied twice daily from the 14th day since wounding. The investigator will be blinded to the topical application given to the patient. Both patient and investigator will assess the scar using Patient \& Observer Scar Assessment Scale (POSAS) version 3.0 and scars will be photographed under fixed camera settings \& lighting conditions. Patients will come for follow-up on weeks 4, 12 \& 24 and the scar assessment will be repeated by both patient \& the same observer. Serial photographs will also be taken each visit. At the end of the 24 weeks, photographs of the scars will be reviewed by three independent plastic surgeons and scored using the Scar Cosmesis \& Assessment Rating (SCAR) Scale. Both the scores from the clinical \& photographic scar assessments will be evaluated to compare the efficacy of each topical application. The duration of the study is from Nov 2025-Nov 2026.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Silicone gel | Active comparator | Device: Silicone GelSilicone gel application twice a day for 8 weeks |
| Chitosan cream | Experimental | Device: Chitosan creamChitosan cream application twice a day for 8 weeks |
| Olive oil | Placebo comparator | Device: Olive Oil Topical OilOlive oil application twice a day for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with traumatic or surgical wounds which have healed by primary intention within 14 days
- Length of scar at least 3cm
Key exclusion criteria (5 listed)
- Patients with seafood allergy
- Patients with scar from wounds that were complicated by infection or wound breakdown
- Patients who have undergone scar treatment by other modalities
- Patients with history of keloids / hypertrophic scars
- Pregnant patients
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 |
|---|---|---|
| Chitosan creamApplication of Chitosan cream twice daily for 8 weeks | Device | Chitosan cream |
| Silicone GelApplication of silicone gel twice a day for 8 weeks | Device | Silicone gel |
| Olive Oil Topical OilApplication of olive oil twice daily for 8 weeks | Device | Olive oil |
Primary outcome
Patient and Observer Scar Assessment Scale (POSAS) scores
Time frame: Enrolment to 24 weeks
Each item is rated on a 5-point score. The lowest score is '1' which corresponds to the situation of normal skin. Score '5' being the largest difference from normal skin.
Scar Assessment and Rating (SCAR) Scale scores
Time frame: Enrolment to 24 weeks
Scores of clinical photographs of each scar by 3 plastic surgeons. Score '0' indicates conditions closest to normal skin. Maximum scores for each item range from 1 to 4, where higher scores indicate larger differences from normal skin.
1 secondary outcome
Side effects
Time frame: Enrolment to 24 weeks
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 2 Jan 2026.
- Background: PubMed 27806156Kantor J. Reliability and Photographic Equivalency of the Scar Cosmesis Assessment and Rating (SCAR) Scale, an Outcome Measure for Postoperative Scars. JAMA Dermatol. 2017 Jan 1;153(1):55-60. doi: 10.1001/jamadermatol.2016.3757.
- Background: PubMed 36355319Carriere ME, Mokkink LB, Tyack Z, Westerman MJ, Pijpe A, Pleat J, van de Kar AL, Brown J, de Vet HCW, van Zuijlen PPM. Development of the Patient Scale of the Patient and Observer Scar Assessment Scale (POSAS) 3.0: a qualitative study. Qual Life Res. 2023 Feb;32(2):583-592. doi: 10.1007/s11136-022-03244-6. Epub 2022 Nov 10.
- Individual participant dataSharing planned: No. Patient privacy protection
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chitosan cream, Silicone Gel and Olive Oil Topical Oil in people with Hypertrophic Scars, run by Universiti Sains Malaysia at 3 sites in Malaysia.
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 2 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: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Malaysia. 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. Some participants in this study may receive a placebo. 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 Esther HM Tan, MBBS (+6097673000, esthertan@student.usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and Observer Scar Assessment Scale (POSAS) scores (time frame: Enrolment to 24 weeks). The study lists 2 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 NCT07269093, which also lists 2 linked publications.
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 2 Jan 2026.