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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how CBD, a compound from cannabis, mixed with silicone affects scar healing and appearance in individuals with a forehead scar after specific reconstructive surgery. The treatment will be applied to half of the scar with the CBD and silicone mix, while the other half will receive only silicone, to determine if CBD provides additional benefits. Individuals who have undergone paramedian forehead flap surgery and speak English may be suitable candidates for this study. As an Early Phase 1 trial, the research aims to understand the treatment's effects in people, offering participants a chance to be among the first to explore potential benefits of CBD in scar healing.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that cannabidiol (CBD) is generally safe when applied to the skin. Studies have found that it can reduce inflammation and aid in wound healing, which may be useful for treating scars. Current evidence suggests that using CBD oil with silicone ointment could safely promote healing of forehead wounds.

While researchers continue to test this specific treatment, CBD has already been studied for other skin conditions. In these studies, participants applied CBD to their skin without major side effects. Although more information is needed about its effectiveness in scar healing, the treatment appears safe based on existing knowledge. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for forehead wounds?

Unlike the standard of care for forehead scars, which typically includes silicone patches alone, the treatment under study combines cannabidiol (CBD) oil with silicone ointment. Researchers are excited about this treatment because CBD is believed to have anti-inflammatory and healing properties, which might enhance scar healing. This combination could potentially provide a dual-action approach: the silicone patch helps flatten and smooth the scar, while the CBD oil may reduce inflammation and promote faster recovery.

What evidence suggests that this trial's treatments could be effective for forehead wound healing?

Research has shown that cannabidiol (CBD) might aid in healing wounds and reducing swelling. In animal studies, CBD initially slowed wound healing but eventually matched the healing speed of untreated wounds. CBD also significantly reduced certain inflammation-causing cells. Participants who used CBD reported better wound healing and less discomfort, such as pain and itching. A special form of CBD, called nanoformulated CBD, which absorbs better into the skin, demonstrated even better healing and anti-inflammatory effects. In this trial, one group will use CBD combined with a silicone patch, while the other will use a silicone patch alone. These findings suggest that CBD could be promising for improving scar healing and appearance. ^{4 6 7 8 9}

Who Is on the Research Team?

Mark Mims, MD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11241632/

Cutaneous Wound Healing and the Effects of Cannabidiol We found an initial delay in the rate of wound closure in B6 mice with CBD, but this difference disappeared with time. CBD decreased IL-33 + cells in B6 by 70% ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06129591

NCT06129591 | Topical CBD Scar Healing Study 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0939641125001614

Review article Nanoformulated cannabidiol for skin disorders Cannabidiol (CBD) nanoformulations enhance skin penetration and bioavailability. Nano-CBD platforms show improved anti-inflammatory and wound healing effects.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/hsr2.1908

The effect of cannabinoids on wound healing: A review Most respondents reported CBD use improved their overall EB symptoms (95%), pain (94%), pruritus (91%), wound healing (81%), and decreased the ...

5. mdpi.com mdpi.com/2218-273X/15/9/1219

Cannabidiol in Skin Health: A Comprehensive Review of ... CBD also relieves pruritus through neuroimmune modulation and promotes wound healing in conditions such as pyoderma gangrenosum and epidermolysis bullosa. In ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11511700/

The Potential Role of Cannabidiol in Cosmetic Dermatology Available in vitro and in vivo evidence suggests that CBD has anti-oxidant, anti-inflammatory, moisturizing, anti-acne, wound-healing, and anti-aging ...

7. mdpi.com mdpi.com/1999-4923/16/8/1081

Cannabinoids in Integumentary Wound Care: A Systematic ... A phase I clinical trial on human acute wound healing on the forehead with CBD oil plus silicone ointment is ongoing [249]. Outcomes from these studies will ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9210160/

Topical cannabidiol (CBD) in skin pathology - PubMed Central Topical cannabis has anti-inflammatory, anti-itching, analgesics, wound healing and anti-proliferative effects on the skin.

9. withpower.com withpower.com/trial/early-phase-1-forehead-wound-11-2022-520e8

Topical CBD for Forehead Wound (TOPSCAR 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 ...