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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing if CBD oil can improve the appearance of forehead scars. It may have anti-inflammatory benefits that can help keep skin healthy.
Who is the study for?
Adults of any gender or ethnicity who have had a Paramedian forehead flap (PMFF) surgery are eligible for this study. It's not suitable for anyone under 18 or those with allergies to CBD.Check my eligibility
What is being tested?
The trial is testing if applying CBD oil, known for its anti-inflammatory effects, on forehead scars can improve their appearance. Participants will use a silicone patch combined with flavorless CBD tincture compared to just the silicone patch.See study design
What are the potential side effects?
CBD oil may cause skin irritation at the site of application, mild itching, redness, or rash. Systemic side effects are unlikely as it's used topically but could include fatigue or changes in appetite.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of CBD Oil's Impact on postoperative scars in paramedian forehead flap reconstruction patients.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Split-scar randomized trial arm with CBD oilExperimental Treatment1 Intervention
The study targets the vertical forehead scar, treating half with CBD oil and a silicone patch (experimental).
Group II: Split-scar randomized trial arm without CBD oilPlacebo Group1 Intervention
The study targets the vertical forehead scar, treating half with a silicone patch (control).
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Who is running the clinical trial?
University of OklahomaLead Sponsor
455 Previous Clinical Trials
95,809 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new participants being recruited for this research project?
"According to clinicaltrials.gov, this trial is not currently open for enrollment; it was last updated on November 8th 2023 and initially posted January 1st 2024. Nevertheless, there are additional medical studies actively seeking participants at the present moment."
Answered by AI
What potential risks are associated with the Split-scar randomized trial arm using CBD oil for patients?
"In view of the scant data available, our team at Power gave Split-scar randomized trial arm with CBD oil a score of 1 for safety. This is in keeping with it being a Phase 1 trial and limited evidence to support its efficacy or protection against harm."
Answered by AI
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