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

June 9, 2008
August 8, 2012
June 2006
August 2007   (final data collection date for primary outcome measure)
To assess the effect of capsaicin on small nerve fiber function in psoriasis [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00697034 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of Capsaicin on the Structure, Distribution, and Function of Cutaneous Small Nerve Fibers in Psoriatic Skin
Effects of Capsaicin on the Structure, Distribution, and Function of Cutaneous Small Nerve Fibers in Psoriatic Skin

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).

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Experimental: 1
Study subjects will be patients with chronic plaque-type psoriasis
Intervention: Drug: Capsaicin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
December 2008
August 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00697034
05-467
No
Gil Yosipovitch, Wake Forest University
Wake Forest School of Medicine
Not Provided
Principal Investigator: Gil Yosipovitch, MD Wake Forest School of Medicine
Wake Forest School of Medicine
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP