Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract

Cicatrix Clinical Trial

Official title:

Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract in Post-cesarean Surgical Scars Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04233320
• Other study ID #: 547/62
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: January 2020
• Source: Chulalongkorn University
• Contact: Pornanong Aramwit, Ph.D
• Phone: +66899217255
• Email: aramwit[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: September 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix

Intervention

Device:
• silicone cream containing Allium Cepa extract
silicone cream containing Allium Cepa extract contains 10% of Allium cepa bulb extract.
• Commercial scar gel
Commercial scar gel is a topical silicone gel. It contains cyclic and polymeric siloxanes and Vitamin C ester.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	Vancouver scar scale	The range of score is 0 to 10. Higher scores mean a worse outcome.	3 months
Secondary	Melanin index	Melanin index will be evaluated using cutometer.	3 months
Secondary	Erythema index	Erythema index will be evaluated using cutometer.	3 months
Secondary	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.	3 months