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Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract

Primary Purpose

Cicatrix

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
silicone cream containing Allium Cepa extract
Commercial scar gel
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cicatrix focused on measuring Scar, Allium Cepa, post-cesarean

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    silicone cream containing Allium Cepa extract

    commercial scar gel

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Vancouver scar scale
    The range of score is 0 to 10. Higher scores mean a worse outcome.
    Melanin index
    Melanin index will be evaluated using cutometer.
    Erythema index
    Erythema index will be evaluated using cutometer.
    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.

    Full Information

    First Posted
    January 15, 2020
    Last Updated
    January 16, 2020
    Sponsor
    Chulalongkorn University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04233320
    Brief Title
    Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract
    Official Title
    Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract in Post-cesarean Surgical Scars Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2020 (Anticipated)
    Primary Completion Date
    June 30, 2020 (Anticipated)
    Study Completion Date
    September 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chulalongkorn University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cicatrix
    Keywords
    Scar, Allium Cepa, post-cesarean

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    silicone cream containing Allium Cepa extract
    Arm Type
    Experimental
    Arm Description
    Silicone cream containing Allium Cepa extract will be applied on half of post-cesarean surgical scars 2 times per day for 3 months.
    Arm Title
    commercial scar gel
    Arm Type
    Active Comparator
    Arm Description
    Commercial scar gel will be applied on half of post-cesarean surgical scars 2 times per day for 3 months.
    Intervention Type
    Device
    Intervention Name(s)
    silicone cream containing Allium Cepa extract
    Intervention Description
    silicone cream containing Allium Cepa extract contains 10% of Allium cepa bulb extract.
    Intervention Type
    Device
    Intervention Name(s)
    Commercial scar gel
    Intervention Description
    Commercial scar gel is a topical silicone gel. It contains cyclic and polymeric siloxanes and Vitamin C ester.
    Primary Outcome Measure Information:
    Title
    Patient and Observer Scar Assessment Scale
    Description
    The range of score is 1 to 10. Noraml skin will be recorded as scale 1. Higher scores mean a worse outcome.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Vancouver scar scale
    Description
    The range of score is 0 to 10. Higher scores mean a worse outcome.
    Time Frame
    3 months
    Title
    Melanin index
    Description
    Melanin index will be evaluated using cutometer.
    Time Frame
    3 months
    Title
    Erythema index
    Description
    Erythema index will be evaluated using cutometer.
    Time Frame
    3 months
    Title
    Adverse effect
    Description
    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.
    Time Frame
    3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pornanong Aramwit, Ph.D
    Phone
    +66899217255
    Email
    aramwit@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract

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