Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract

NCT04233320 | Unknown DMC

• 1 other identifier: 547/62
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cicatrix

Keywords

Scar; Allium Cepa; post-cesarean

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Vancouver scar scale

  3 months

• Melanin index

  3 months

• Erythema index

  3 months

• Adverse effect

  3 months

Study Arms (2)

silicone cream containing Allium Cepa extract

EXPERIMENTAL

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

commercial scar gel

ACTIVE COMPARATOR

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

Device: Commercial scar gel

Interventions

silicone cream containing Allium Cepa extract DEVICE

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

silicone cream containing Allium Cepa extract

Commercial scar gel DEVICE

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

commercial scar gel

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pornanong Aramwit, Ph.D

CONTACT

+66899217255; aramwit@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: February 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: September 30, 2020
• Last Updated: January 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share