Effects of Capsaicin on the Structure, Distribution, and Function of Cutaneous Small Nerve Fibers in Psoriatic Skin

NCT ID: NCT00697034

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-12-31

Brief Summary

The purpose of this research study is to examine the role of nerves in the skin in psoriasis and to better understand the effects of capsaicin in psoriasis.In this study, capsaicin will be compared to a moisturizer (aquaphor ointment).

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Study subjects will be patients with chronic plaque-type psoriasis

Group Type: EXPERIMENTAL

Capsaicin

Intervention Type: DRUG

natural alkaloid derived from hot chili peppers and activates vanilloid receptors that are also activated by endogenous cannabinoid anandamide applied three times daily

Interventions

Capsaicin

natural alkaloid derived from hot chili peppers and activates vanilloid receptors that are also activated by endogenous cannabinoid anandamide applied three times daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult men and women who are 18 years of age or older.
• Diagnosis of plaque-type psoriasis is required to be confirmed by clinical criteria.
• Subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of psoriasis or which would increase their health risk by study participation.
• Subjects must be willing to receive topical capsaicin weekly for 6 weeks and must be willing to undergo 3mm punch biopsies at baseline and at week 6.
• Subjects may not receive any systemic therapies during the study.
• Subjects are required to complete a 4 week washout period from any systemic medication and/or phototherapy prior to enrolling in the study.
• Stable use of moisturizers will be allowed provided that use has been stable for at least 14 days.
• Women of child bearing age will be required to have a negative pregnancy test in order to enroll in the study and will be required to maintain adequate birth control throughout the study.

Exclusion Criteria

• Subjects who are unable to complete the required measures.
• Subjects diagnosed with other skin diseases that would affect the measurement of cutaneous blood flow.
• Subjects with any history of any disease associated with neuropathy, including diabetes, alcoholism, uremia, HIV infection, hypothyroidism, or cancer chemotherapy.
• Subjects who are currently enrolled in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy and subjects undergoing treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
• Subjects who have used any topical therapy for psoriasis or other skin diseases in the past 7 days.
• Subjects receiving any of the following treatments or agents within the 28 days prior to investigational drug administration will be excluded: systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab, adalimumab or mofetil or other systemic immunosuppressant, and phototherapy, including Ultraviolet B (UVB) and Psoralen + Ultraviolet A (PUVA).
• Subjects with a known allergy to capsaicin.
• Children less than 18 years of age.
• Pregnant women.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gil Yosipovitch, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

05-467

Identifier Type: -

Identifier Source: org_study_id