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Thermosensitivity of a Topical Palmitated Formulation of Capsaicin

NCT05649228 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-03-21

No results posted yet for this study

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

Interventions

DRUG

Capsaicin 0.1% Cream

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.

DRUG

Capsaicin Palmitate 0.25% Cream

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.

DRUG

Placebo Cream

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.

Sponsors & Collaborators

  • Chorda Pharma, Inc.

    collaborator UNKNOWN

  • Carilion Clinic

    lead OTHER

Principal Investigators

  • Zachary Holcomb, MD · Carilion Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-13
Primary Completion
2024-01-11
Completion
2024-01-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05649228 on ClinicalTrials.gov