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

NCT07269093 | Recruiting

• 1 other identifier: USM/JEPeM/KK/25060539
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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 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

Conditions

Hypertrophic Scars

Keywords

Chitosan; silicone gel; olive oil; hypertrophic scars; prevention

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Enrolment to 24 weeks

Secondary Outcomes (1)

• Side effects

  Enrolment to 24 weeks

Study Arms (3)

Silicone gel

ACTIVE COMPARATOR

Silicone gel application twice a day for 8 weeks

Device: Silicone Gel

Chitosan cream

EXPERIMENTAL

Chitosan cream application twice a day for 8 weeks

Device: Chitosan cream

Olive oil

PLACEBO COMPARATOR

Olive oil application twice a day for 8 weeks

Device: Olive Oil Topical Oil

Interventions

Chitosan cream DEVICE

Application of Chitosan cream twice daily for 8 weeks

Chitosan cream

Silicone Gel DEVICE

Application of silicone gel twice a day for 8 weeks

Silicone gel

Olive Oil Topical Oil DEVICE

Application of olive oil twice daily for 8 weeks

Olive oil

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (3)

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, 15586, Malaysia

NOT YET RECRUITING

Hospital Pakar Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

RECRUITING

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 27806156 BACKGROUND

• Carriere 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.

  PMID: 36355319 BACKGROUND

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Esther HM Tan, MBBS

CONTACT

+6097673000; esthertan@student.usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 8, 2025
• Study Start: December 21, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (3)