Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-09-30

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.

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Detailed Description

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Conditions

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Cicatrix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

silicone cream containing Allium Cepa extract

Intervention Type DEVICE

silicone cream containing Allium Cepa extract contains 10% of Allium cepa bulb extract.

commercial scar gel

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

Group Type ACTIVE_COMPARATOR

Commercial scar gel

Intervention Type DEVICE

Commercial scar gel is a topical silicone gel. It contains cyclic and polymeric siloxanes and Vitamin C ester.

Interventions

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silicone cream containing Allium Cepa extract

silicone cream containing Allium Cepa extract contains 10% of Allium cepa bulb extract.

Intervention Type DEVICE

Commercial scar gel

Commercial scar gel is a topical silicone gel. It contains cyclic and polymeric siloxanes and Vitamin C ester.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes