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Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract

Sponsor
Chulalongkorn University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04233320
Collaborator
(none)
22
Enrollment
2
Arms
8
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: silicone cream containing Allium Cepa extract
  • Device: Commercial scar gel
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract in Post-cesarean Surgical Scars Treatment
Anticipated Study Start Date :
Feb 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2020
Anticipated Study Completion Date :
Sep 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Patient and Observer Scar Assessment Scale [3 months]

    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

  1. Vancouver scar scale [3 months]

    The range of score is 0 to 10. Higher scores mean a worse outcome.

  2. Melanin index [3 months]

    Melanin index will be evaluated using cutometer.

  3. Erythema index [3 months]

    Erythema index will be evaluated using cutometer.

  4. Adverse effect [3 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Chulalongkorn University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pornanong Aramwit, Pharm.D., Ph.D, Professor, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT04233320
Other Study ID Numbers:
  • 547/62
First Posted:
Jan 18, 2020
Last Update Posted:
Jan 21, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pornanong Aramwit, Pharm.D., Ph.D, Professor, Chulalongkorn University
Scar
Allium Cepa
post-cesarean
Additional relevant MeSH terms:
Cicatrix

Study Results

No Results Posted as of Jan 21, 2020