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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00697034
Recruitment Status : Terminated (Lack of qualified and willing volunteers.)
First Posted : June 13, 2008
Last Update Posted : February 17, 2017
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

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).

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Capsaicin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Capsaicin on the Structure, Distribution, and Function of Cutaneous Small Nerve Fibers in Psoriatic Skin
Study Start Date : June 2006
Primary Completion Date : August 2007
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. To assess the effect of capsaicin on small nerve fiber function in psoriasis [ Time Frame: 1 day ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00697034

United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Principal Investigator: Gil Yosipovitch, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Identifier: NCT00697034     History of Changes
Other Study ID Numbers: 05-467
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs