Efficacy in Preventing Hypertrophic Scars: A Randomised Controlled Trial Comparing Chitosan Cream, Silicone Gel & Olive Oil

December 28, 2025 updated by: Esther Tan Hui Min, Universiti Sains Malaysia

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 15586
        • Not yet recruiting
        • Hospital Raja Perempuan Zainab Ii
        • Sub-Investigator:
          • Aida Nadhirah Nor Azizan, MBBS
        • Principal Investigator:
          • Esther HM Tan, MBBS
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Recruiting
        • Hospital Pakar Universiti Sains Malaysia
        • Contact:
        • Principal Investigator:
          • Esther HM Tan, MBBS
        • Sub-Investigator:
          • Amirul Akram Ahmad Sukari, MBBS
        • Sub-Investigator:
          • Nor Aida Azizan, MBBS
        • Sub-Investigator:
          • Ahmad Sukari Halim, MD
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
        • Not yet recruiting
        • Hospital Kuala Lumpur
        • Principal Investigator:
          • Esther HM Tan, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with traumatic or surgical wounds which have healed by primary intention within 14 days
  • Length of scar at least 3cm

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Silicone gel
Silicone gel application twice a day for 8 weeks
Device: Silicone Gel
Application of silicone gel twice a day for 8 weeks
Experimental: Chitosan cream
Chitosan cream application twice a day for 8 weeks
Device: Chitosan cream
Application of Chitosan cream twice daily for 8 weeks
Placebo Comparator: Olive oil
Olive oil application twice a day for 8 weeks
Device: Olive Oil Topical Oil
Application of olive oil twice daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Enrolment to 24 weeks
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.
Enrolment to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: Enrolment to 24 weeks
Patients are to report any side effects that they experience with use of any topical application. Side effects encountered are recorded.
Enrolment to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Estimated)

December 8, 2025

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 28, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USM/JEPeM/KK/25060539

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient privacy protection

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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