CicatrixNCT04233320
Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract
A study testing silicone cream containing Allium Cepa extract and Commercial scar gel in people with Cicatrix, run by Chulalongkorn University.
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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cicatrix
- What is being tested?
- silicone cream containing Allium Cepa extract and Commercial scar gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract in Post-cesarean Surgical Scars Treatment
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
- Being tested
- silicone cream containing Allium Cepa extract, Commercial scar gel
- Keywords
- Scar, Allium Cepa, post-cesarean
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silicone cream containing Allium Cepa extractDevice
silicone cream containing Allium Cepa extract contains 10% of Allium cepa bulb extract.
Commercial scar gelDevice
Commercial scar gel is a topical silicone gel. It contains cyclic and polymeric siloxanes and Vitamin C ester.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Commercial scar gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
Vancouver scar scale
The range of score is 0 to 10. Higher scores mean a worse outcome.
Measured: 3 months
Melanin index
Melanin index will be evaluated using cutometer.
Measured: 3 months
Erythema index
Erythema index will be evaluated using cutometer.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CicatrixStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233320
- Sponsor's protocol ID
- 547/62
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2020
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract in Post-cesarean Surgical Scars Treatment
- ClinicalTrials.gov ID
- NCT04233320
- Acronym / sponsor ID
- 547/62
- Conditions
- Cicatrix
- Keywords
- Scar, Allium Cepa, post-cesarean
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| silicone cream containing Allium Cepa extract | Experimental | Device: silicone cream containing Allium Cepa extractSilicone 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 | Active comparator | Device: Commercial scar gelCommercial scar gel will be applied on half of post-cesarean surgical scars 2 times per day for 3 months. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| silicone cream containing Allium Cepa extractsilicone cream containing Allium Cepa extract contains 10% of Allium cepa bulb extract. | Device | silicone cream containing Allium Cepa extract |
| Commercial scar gelCommercial scar gel is a topical silicone gel. It contains cyclic and polymeric siloxanes and Vitamin C ester. | Device | commercial scar gel |
Primary outcome
Patient and Observer Scar Assessment Scale
Time frame: 3 months
The range of score is 1 to 10. Noraml skin will be recorded as scale 1. Higher scores mean a worse outcome.
4 secondary outcomes
Vancouver scar scale
Time frame: 3 months
Melanin index
Time frame: 3 months
Erythema index
Time frame: 3 months
Adverse effect
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing silicone cream containing Allium Cepa extract and Commercial scar gel in people with Cicatrix, run by Chulalongkorn University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pornanong Aramwit, Ph.D (+66899217255, aramwit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and Observer Scar Assessment Scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020.