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

This study has been terminated.
(Lack of qualified and willing volunteers.)
Sponsor:
Information provided by (Responsible Party):
Gil Yosipovitch, Wake Forest University
ClinicalTrials.gov Identifier:
NCT00697034
First received: June 9, 2008
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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).


Condition Intervention Phase
Psoriasis
Drug: Capsaicin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Capsaicin on the Structure, Distribution, and Function of Cutaneous Small Nerve Fibers in Psoriatic Skin

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • To assess the effect of capsaicin on small nerve fiber function in psoriasis [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: June 2006
Study Completion Date: December 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Study subjects will be patients with chronic plaque-type psoriasis
Drug: Capsaicin
natural alkaloid derived from hot chili peppers and activates vanilloid receptors that are also activated by endogenous cannabinoid anandamide applied three times daily
Other Name: Capsaicin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697034

Locations
United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Gil Yosipovitch, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Gil Yosipovitch, Professor, Wake Forest University
ClinicalTrials.gov Identifier: NCT00697034     History of Changes
Other Study ID Numbers: 05-467
Study First Received: June 9, 2008
Last Updated: August 8, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Capsaicin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014