Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract

Chulalongkorn University

Status: Unknown

Conditions: Cicatrix

Treatments: Device: Commercial scar gel; Device: silicone cream containing Allium Cepa extract

Study type: Interventional

Funder types: Other

Identifiers

NCT04233320

547/62

Details and patient eligibility

About

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.

Enrollment: 22 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups

silicone cream containing Allium Cepa extract

Experimental group

Description:

Silicone cream containing Allium Cepa extract will be applied on half of post-cesarean surgical scars 2 times per day for 3 months.

Treatment:

Device: silicone cream containing Allium Cepa extract

commercial scar gel

Active Comparator group

Description:

Commercial scar gel will be applied on half of post-cesarean surgical scars 2 times per day for 3 months.

Treatment:

Device: Commercial scar gel