Topical CBD for Forehead Wound

(TOPSCAR Trial)

Overseen By Lead Nurse

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Oklahoma

Must not be taking: CNS depressants, Hepatotoxic drugs

Disqualifiers: Hepatic impairment, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

22 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking medications that affect the central nervous system (like alcohol) or drugs that could harm the liver, you might need to stop those. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment for forehead wounds?

Research suggests that CBD may have anti-inflammatory properties, which could help in the early phase of wound healing, as seen in studies on oral wounds in rats and skin conditions. However, its ability to improve wound healing clinically is not clearly established. ^{1 2 3 4 5}

Is topical CBD safe for use in humans?

There is limited safety data on topical CBD in humans, but studies on oral CBD have reported some adverse effects. More research is needed to determine the safety of topical CBD products. ^{2 5 6 7 8}

How does the topical CBD oil with silicone ointment treatment for forehead wounds differ from other treatments?

This treatment is unique because it combines CBD oil, known for its anti-inflammatory and pain-relieving properties, with silicone ointment, which is often used to improve scar appearance. Unlike other treatments, this combination may offer enhanced skin healing and scar reduction benefits. ^{3 6 9 10 11}

What is the purpose of this trial?

The purpose of this study is to find out what effects (good and bad) that cannabidiol (CBD) has on scar healing and appearance in patients who have undergone paramedian forehead flap reconstruction.

Research Team

Mark Mims, MD

Principal Investigator

University of Oklahoma

Eligibility Criteria

Adults of any gender or ethnicity who have had a paramedian forehead flap (PMFF) reconstruction can join this study. It's designed to see how well CBD with silicone ointment works on healing scars compared to just using a silicone patch.

Inclusion Criteria

I am over 18 and have had a PMFF procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply a silicone patch to half of the scar and CBD oil ointment with silicone patch to the other half twice a day for 2 months

8 weeks

Regular follow-up appointments for questionnaire completion and photographic evaluation

Follow-up

Participants are monitored for scar healing and appearance, with photographic evaluations and SCAR scale assessments

7 months

Long-term follow-up

Participants are monitored for any skin side effects and overall scar outcomes

2 years

Treatment Details

Interventions

• Cannabidiol (CBD) oil with silicone ointment

Trial Overview The trial is testing the effectiveness of topical cannabidiol (CBD) combined with silicone ointment versus a standard silicone patch in improving scar outcomes after forehead wound surgery.

Participant Groups

Group I: CBD + Silicone Experimental Treatment 1 Intervention

Split-scar randomized trial arm with CBD The study targets the vertical forehead scar, treating half with CBD and a silicone patch (experimental).

Group II: Silicone Only Active Control 1 Intervention

Split-scar randomized trial arm without CBD The study targets the vertical forehead scar, treating the other scar half with a silicone patch (control).

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Findings from Research

Cannabidiol (CBD) has been FDA-approved for treating severe epilepsy syndromes like Dravet and Lennox-Gastaut, demonstrating its therapeutic efficacy, but it is not without risks.

CBD can cause adverse effects such as drug-drug interactions, liver abnormalities, and gastrointestinal issues in humans, and potential developmental toxicity in animals, which clinicians should consider before recommending it for off-label use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol Adverse Effects and Toxicity. Huestis, MA., Solimini, R., Pichini, S., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of topical treatment of cannabidiol extract in a unique manuka factor 5 manuka honey carrier on second intention wound healing on equine distal limb wounds: a preliminary study. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Effects of cannabidiol, a Cannabis sativa constituent, on oral wound healing process in rats: Clinical and histological evaluation. [2018]

3. Italy pubmed.ncbi.nlm.nih.gov

A therapeutic effect of cbd-enriched ointment in inflammatory skin diseases and cutaneous scars. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Anti-inflammation and gingival wound healing activities of Cannabis sativa L. subsp. sativa (hemp) extract and cannabidiol: An in vitro study. [2022]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Cannabidiol Adverse Effects and Toxicity. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Probable cutaneous adverse drug reaction due to a cannabidiol-containing hemp oil product in a dog. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Lack of evidence for the effectiveness or safety of over-the-counter cannabidiol products. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

Effects of cannabidiol without delta-9-tetrahydrocannabinol on canine atopic dermatitis: A retrospective assessment of 8 cases. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of the in vitro Anti-Inflammatory Effect of Cannabidiol to Dexamethasone. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

In Vitro and Clinical Evaluation of Cannabigerol (CBG) Produced via Yeast Biosynthesis: A Cannabinoid with a Broad Range of Anti-Inflammatory and Skin Health-Boosting Properties. [2022]

11. Singapore pubmed.ncbi.nlm.nih.gov

Cannabidiol (CBD) with 4',7-Isoflavandiol (Equol) Efficacy is Greater than CBD or Equol Treatment Alone via Human Skin Gene Expression Analysis. [2023]