Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract in Post-cesarean Surgical Scars Treatment

Conditions
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Cicatrix

Intervention / Treatment
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* Device: silicone cream containing Allium Cepa extract
* Device: Commercial scar gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: silicone cream containing Allium Cepa extract<br>Silicone cream containing Allium Cepa extract will be applied on half of post-cesarean surgical scars 2 times per day for 3 months. | Device: silicone cream containing Allium Cepa extract<br>* silicone cream containing Allium Cepa extract contains 10% of Allium cepa bulb extract.<br>|
| Active Comparator: commercial scar gel<br>Commercial scar gel will be applied on half of post-cesarean surgical scars 2 times per day for 3 months. | Device: Commercial scar gel<br>* Commercial scar gel is a topical silicone gel. It contains cyclic and polymeric siloxanes and Vitamin C ester.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and Observer Scar Assessment Scale | The range of score is 1 to 10. Noraml skin will be recorded as scale 1. Higher scores mean a worse outcome. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vancouver scar scale | The range of score is 0 to 10. Higher scores mean a worse outcome. | 3 months | 
| Melanin index | Melanin index will be evaluated using cutometer. | 3 months | 
| Erythema index | Erythema index will be evaluated using cutometer. | 3 months | 
| Adverse effect | Adverse effect will be observed in term of erythema, edema, papules, vesicles, and bullae. The range of erythema score is 0 to 3. The range of edema score is 0 to 4. Higher scores mean a worse outcome. Papules, vesicles, and bullae will be recorded as apperance or clear. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scar, Allium Cepa, post-cesarean