Thermosensitivity of a Topical Palmitated Formulation of Capsaicin

NCT05649228 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB-21-1214
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• Determine any change in relative burning potential for capsaicin palmitate in comparison to non-palmitated capsaicin and to placebo.

  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.

  Assess for changes every 10 minutes after application for one hour

Secondary Outcomes (2)

• Determine the presence and time course of erythema.

  Assessed every 10 minutes after application for one hour

• Determine the presence and time course of skin irritation

  Assessed every 10 minutes after application for one hour

Study Arms (3)

Capsaicin Palmitate

EXPERIMENTAL

Cream containing 0.25% capsaicin palmitate will be applied to an 8 cm2 area of skin on the subject's forearm

Drug: Capsaicin 0.1% Cream; Drug: Placebo Cream

Capsaicin

ACTIVE COMPARATOR

Cream containing 0.1% capsaicin will be applied to an 8 cm2 area of skin on the subject's forearm

Drug: Capsaicin Palmitate 0.25% Cream; Drug: Placebo Cream

Placebo Cream

PLACEBO COMPARATOR

Placebo cream will be applied to an 8 cm2 area of skin on the subject's forearm

Drug: Capsaicin 0.1% Cream; Drug: Capsaicin Palmitate 0.25% Cream

Interventions

Capsaicin 0.1% Cream DRUG

A small amount of cream about the size of a U.S. quarter containing 0.10% non-palmitated capsaicin will be applied to participant's forearm using gloved fingers with visible cream left on the surface for one hour.

Also known as: Zostrix

Capsaicin Palmitate; Placebo Cream

Capsaicin Palmitate 0.25% Cream DRUG

A small amount of cream about the size of a U.S. quarter containing 0.25% capsaicin palmitate will be applied to participant's forearm using gloved fingers with visible cream left on the surface for one hour.

Also known as: Capsadyn

Capsaicin; Placebo Cream

Placebo Cream DRUG

A small amount of cream about the size of a U.S. quarter will be applied to participant's forearm using gloved fingers with visible cream left on the surface for one hour.

Capsaicin; Capsaicin Palmitate

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carilion Clinic: lead
• Chorda Pharma, Inc.: collaborator

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Zachary Holcomb, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Labeling codes will be used for a double-blind procedure. Packaging is done by Chorda Pharma.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each subject will be given two of either: 1. vehicle cream containing 0.25% capsaicin palmitate 2. vehicle cream containing 0.10% non-palmitated capsaicin 3. vehicle cream alone (placebo)

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 14, 2022
• Study Start: December 13, 2022
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)