Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract

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

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.

Study Overview

• Status: Unknown
• Conditions: Cicatrix
• Intervention / Treatment: Device: silicone cream containing Allium Cepa extract; Device: Commercial scar gel

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 21, 2020
• Last Update Submitted That Met QC Criteria: January 16, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Scar; post-cesarean; Allium Cepa
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: 547/62

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No