Effect of Topical CBD Cream for Degenerative Hallux Disorders

NCT04103814 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 19052902
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Hallux rigidus and hallux valgus are chronic forefoot conditions associated with pain, inflammation and functional impairment. Topical cannabidiol (CBD) cream has been shown to decrease inflammation, swelling, and pain response in arthritis models with minimal side effects, although the intervention has never been studied in hallux valgus or hallux rigidus. The purpose of this study is to determine if topical CBD cream is an effective treatment for pain secondary to hallux rigidus and hallux valgus.

Conditions

Hallux Valgus; Hallux Rigidus

Outcome Measures

Primary Outcomes (2)

• Post-treatment VAS Score Averaged Daily Over 4 Weeks.

  Weekly visual analog system (VAS) pain scores will be measured daily for four weeks. The VAS pain score is a measure of pain severity. It is measured on a scale from 0 to 10, with 10 being the worst pain the patient has experienced. No patients completed full enrollment so no data was analyzed.

  4 weeks

• Weekly Foot Function Index

  The foot function index (FFI) is a questionnaire that measures foot pain and disability. It is self-administered and consists of 23 items divided into 3 subscales (pain, disability, and activity limitation). The pain subcategory consists of 9 questions (scored out of 90) and is a measure of pain in different situations, such as walking with shoes versus barefoot. The disability subcategory consists of 9 questions (scored out of 90) and measures functional activities, such as difficulty walking upstairs. The activity limitation subcategory consists of 5 questions (scored out of 50) and measures limitations caused by the foot problem. All three subcategories are summed together to get a final number, with higher numbers indicating worse pain.

  4 weeks

Study Arms (2)

Mg-CBDa cream

ACTIVE COMPARATOR

Subjects in this group will receive the active Mg-CBDa (magnesium-cannabidiolic acid) for topical treatment of hallux valgus or hallux rigidus.

Drug: magnesium-cannabidiolic acid cream

Placebo cream

PLACEBO COMPARATOR

Subjects in this group will receive the inactive CBD cream for topical treatment of hallux valgus or hallux rigidus. The ingredients of the placebo cream are: butyrospermum parkii (shea butter), caprylic/capric triglycerides medium-chain triglycerides (MCT oil), and food coloring to match the CBD oil. There will be 345 grams of shea butter and 62ml MCT oil per batch.

Drug: Placebo cream

Interventions

magnesium-cannabidiolic acid cream DRUG

Patients will receive Mg-CBDa (magnesium-cannabidiolic acid) cream for topical treatment of hallux rigidus or hallux valgus.

Mg-CBDa cream

Placebo cream DRUG

Patients will receive placebo cream (neutral emollient containing no active agent) for topical treatment of hallux rigidus or hallux valgus. The ingredients of the placebo cream are as follows: Butyrospermum parkii (shea butter), caprylic/capric triglycerides medium-chain triglycerides (MCT oil), food coloring to match the CBD oil. There will be 345 grams of shea butter and 62ml MCT oil per batch.

Placebo cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a new diagnosis of hallux rigidus or hallux valgus
• VAS pain score of 4 or higher
• Age \> 18 years
• The patient provides informed consent

You may not qualify if:

• A previous operative procedure to the first metatarsal for treatment of hallux valgus or hallux rigidus
• VAS pain score at presentation less than 4
• Concomitant hallux valgus and hallux rigidus on the ipsilateral side
• Allergy to CBD, Cannabidiolic acid (CBDa) or any other ingredient contained in the topical cream
• Pregnant patients

Sponsors & Collaborators

• Rush University Medical Center: lead
• Mid-America Orthopaedic Association: collaborator

Study Sites (1)

Midwest Orthopaedics at Rush

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Hallux Valgus; Hallux Rigidus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Acquired; Joint Diseases

Results Point of Contact

• Title: Dr E Bailey Terhune
• Organization: Rush University Medical cEnter

bailey.terhune@rushortho.com

8018249805

Study Officials

• Simon Lee, MD

  Midwest Orthopaedics at Rush

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolled patients will receive either active Mg-CBDa (magnesium-cannabidiolic acid) cream or placebo cream (neutral emollient containing no active agent) for topical treatment of hallux rigidus or hallux valgus.

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: October 20, 2019
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)