Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract

Not Applicable

• Conditions: Cicatrix
• Interventions: Device: Commercial scar gel; Device: silicone cream containing Allium Cepa extract

• Registration Number: NCT04233320
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-15
• Last Update Submitted: 2020-01-16
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-21
• Study Start: 2020-02-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
commercial scar gel	Commercial scar gel	Commercial scar gel will be applied on half of post-cesarean surgical scars 2 times per day for 3 months.
silicone cream containing Allium Cepa extract	silicone cream containing Allium Cepa extract	Silicone cream containing Allium Cepa extract will be applied on half of post-cesarean surgical scars 2 times per day for 3 months.

Primary Outcome Measures

Name	Time	Method
Patient and Observer Scar Assessment Scale	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 Outcome Measures

Name	Time	Method
Vancouver scar scale	3 months	The range of score is 0 to 10. Higher scores mean a worse outcome.
Melanin index	3 months	Melanin index will be evaluated using cutometer.
Erythema index	3 months	Erythema index will be evaluated using cutometer.
Adverse effect	3 months	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.