Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract
NCT04233320 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2020-01-21
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.
Conditions
- Cicatrix
Interventions
- DEVICE
-
silicone cream containing Allium Cepa extract
silicone cream containing Allium Cepa extract contains 10% of Allium cepa bulb extract.
- DEVICE
-
Commercial scar gel
Commercial scar gel is a topical silicone gel. It contains cyclic and polymeric siloxanes and Vitamin C ester.
Sponsors & Collaborators
-
Chulalongkorn University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-02-01
- Primary Completion
- 2020-06-30
- Completion
- 2020-09-30
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