Thermosensitivity of a Topical Palmitated Formulation of Capsaicin

Early Phase 1

Completed

• Conditions: Pain Management
• Interventions: Drug: Capsaicin 0.1% Cream; Drug: Capsaicin Palmitate 0.25% Cream; Drug: Placebo Cream

• Registration Number: NCT05649228
• Lead Sponsor: Carilion Clinic

Brief Summary

This is a study of the effects of capsaicin, the ingredient that makes hot peppers hot. Capsaicin is currently used in topical ointments to provide temporary relief of minor aches and joint pain associated with arthritis, simple backache, strains, and sprains.

This is a pilot research study that compares the potential of two different capsaicin creams to cause irritation or burning sensation when a small amount (about the size of a quarter) is applied to each forearm of a participant. The amount of capsaicin used in the creams is the same as those found in over-the-counter capsaicin products. The test creams are experimental.

Detailed Description

The study design will detect levels of patient dysesthesia in response to Capsadyn using a three-arm, group comparison. Capsadyn will be compared to an active control \[capsaicin alone (Cap)\], and to a placebo cream alone (PL). The design will use a double-blind for assignment of test article to the three arms. Both the test article administrator and patient will be blinded to test article identity. The test article will be packaged in a coded, white-label, jar with cotton swab applicator.

Participants. Participants for the clinical trial will be recruited through the Carilion Clinic Dermatology Department in Roanoke, VA. In order to minimize the skin area exposed to capsaicin, test articles will be administered to about an 8 cm2 area of the volar forearm. Subject will be informed of the possibility of a transient capsaicin-induced burning sensation along with redness.

Study Groups. The groups are designated Pal and Cap or PL, a placebo (PL) group. The capsaicin drugs are topical analgesics for the temporary relief of minor aches and pains of muscles and joints associated with arthritis. Pal is 0.25% palmitated capsaicin. Cap is 0.10% capsaicin alone and is an active comparator. PL is vehicle alone. Test articles will be balanced arm-to-arm by Pal/Cap, Pal/PL, Cap/PL. Pretest baseline scores will be compared to treatment scores by one-way ANOVA followed by post-hoc analyses for Pal vs PL, Pal vs Cap, and Cap vs PL.

An active comparator is used since non-palmitated capsaicin (unprotected) produces heat. The sensory stimuli would break a neutral control such as vehicle alone. Zostrix at 0.1% capsaicin was used as the active comparator (Cap), a commercially-available topical capsaicin analgesic sold over-the-counter. The concentration of 0.25% capsaicin for Capsadyn (Pal), was based on the upper-limit concentration for capsaicin as specified by the FDA Tentative Final Monograph. A PL group is included since the placebo effect has to be assumed to be intrinsic to pharmaceutical intervention studies. If a placebo effect occurs that would interfere with assessment of the test article intervention, then those assessments can be evaluated with respect to the placebo group.

Study Timeline

• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2022-12-09
• Study Start: 2022-12-13
• Study First Posted: 2022-12-14
• Primary Completion: 2024-01-11
• Study Completion: 2024-01-11
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• 35 to 75 years of age
• Has two arms
• Has intact, unscarred skin over forearms
• Absence of any eczema, hyperkeratosis, scleroderma or other dermatological conditions afflicting the area of test article application that may interfere with absorption as determined by the PI.
• Must agree to not wash forearms during the study period unless a highly uncomfortable burning sensitivity occurs.
• Must be willing to use treatments blinded.
• Must be willing and able to comply with protocol requirements for the duration of study participation, including answering VAS queries in good faith and as diligently as possible.

Read More

Exclusion Criteria

• Younger than 35 and older than 75 years of age
• No previous use of capsaicin products for 48 hours prior to time 0 (application) of test articles.
• Any dermatological conditions that in the judgement of the study site investigator has the potential to disrupt skin integrity or alter sensory function on the forearms.
• Any skin infection, skin irritation (e.g. poison oak), history of eczema, trauma or burn (including sunburn) on the forearms within 30 days preceding application of test article.
• Any recent medical history of painful conditions, surgery, or injury involving or affecting the forearms that may impede skin sensitivity.
• Use of any topically applied products at any location, including prescription or over-the-counter (OTC) analgesic creams/lotions/patches, non-steroidal anti-inflammatory drugs, counter-irritants, local anesthetics, steroids 24 hours prior to the application visit.
• History or current substance abuse including alcoholism/alcohol abuse, as judged by the study site investigator.
• History of hypersensitivity to capsaicin (i.e. chili peppers or OTC capsaicin products).
• At least 30 days since prior topical medications to the skin of the forearms except for emollients or sunscreens.
• No concurrent therapy that may interfere with clinical evaluations.
• No concurrent enrollment in another clinical trial.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capsaicin Palmitate	Placebo Cream	Cream containing 0.25% capsaicin palmitate will be applied to an 8 cm2 area of skin on the subject's forearm
Capsaicin	Placebo Cream	Cream containing 0.1% capsaicin will be applied to an 8 cm2 area of skin on the subject's forearm
Capsaicin Palmitate	Capsaicin 0.1% Cream	Cream containing 0.25% capsaicin palmitate will be applied to an 8 cm2 area of skin on the subject's forearm
Capsaicin	Capsaicin Palmitate 0.25% Cream	Cream containing 0.1% capsaicin will be applied to an 8 cm2 area of skin on the subject's forearm
Placebo Cream	Capsaicin 0.1% Cream	Placebo cream will be applied to an 8 cm2 area of skin on the subject's forearm
Placebo Cream	Capsaicin Palmitate 0.25% Cream	Placebo cream will be applied to an 8 cm2 area of skin on the subject's forearm

Primary Outcome Measures

Name	Time	Method
Determine any change in relative burning potential for capsaicin palmitate in comparison to non-palmitated capsaicin and to placebo.	Assess for changes every 10 minutes after application for one hour	Subject assessment of any changes in the presence of a burn using a VAS scale 0 to 10 for both areas of the forearms where topical cream was applied.

Secondary Outcome Measures

Name	Time	Method
Determine the presence and time course of erythema.	Assessed every 10 minutes after application for one hour	The presence of erythema will be noted and qualified by a clinician erythema assessment scale of 1-4 with 1 being almost clear of redness and 4 being severe redness.
Determine the presence and time course of skin irritation	Assessed every 10 minutes after application for one hour	Subjects will be asked to assess any tingling, burning, soothing, freezing, and itching of the skin in the area where the topical cream was applied.

Trial Locations

Locations (1)

Carilion Clinic; 🇺🇸 Roanoke, Virginia, United States