Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract in Post-cesarean Surgical Scars Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cicatrix
- Sponsor
- Chulalongkorn University
- Enrollment
- 22
- Primary Endpoint
- Patient and Observer Scar Assessment Scale
- Last Updated
- 6 years ago
Overview
Brief Summary
The objectives of this study were to evaluate efficacy and safety of silicone cream containing Allium Cepa extract in post-cesarean surgical scars treatment. Post-cesarean surgical scars were equally seperated into 2 parts (left part and right part). Silicone cream containing Allium Cepa extract or commercial scar gel was ramdomly assigned to apply on left part or right part of the scar. They will be applied 2 times per day (morning and evening) for 3 months. Patient and Observer Scar Assessment Scale (POSAS) , Vancouver scar scale (VSS), melanin index, and erythema index (using cutometer) were used for scar evaluation at 0, 1,2,and 3 months. Moreover, adverse effects were also observed.
Investigators
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University
Eligibility Criteria
Inclusion Criteria
- •Age 18-40 years
- •Have Post-Cesarean Surgical Scars at least 1 month
- •REEDA scale = 0 score
- •Able to read and write Thai
- •Able to follow the research plan
- •Able to meet all the researchers throughout the period of participation in the project
Exclusion Criteria
- •Apply other topical application at the post-cesarean surgical scars within 2 weeks before participating in the study and during the study
- •There is radiation in the area of the post-cesarean surgical scars
- •Chronic skin diseases such as psoriasis, chronic dermatitis, allergies
- •Immune deficient or use immunosuppressants within 2 weeks before participating in the study and during the study
- •Have a history of silicone allergy or onion extract
Outcomes
Primary Outcomes
Patient and Observer Scar Assessment Scale
Time Frame: 3 months
The range of score is 1 to 10. Noraml skin will be recorded as scale 1. Higher scores mean a worse outcome.
Secondary Outcomes
- Vancouver scar scale(3 months)
- Melanin index(3 months)
- Erythema index(3 months)
- Adverse effect(3 months)