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Harbor-UCLA: Effects of Topical Cortiocosteroids on PV Skin Strength

To see if topical (applied to the skin) corticosteroid strengthens the skin of patients with Pemphigus vulgaris, thereby preventing blisters from forming.  The topical corticosteroid to be used in this study is called Clobetasol.  Clobetasol has been approved by the U.S. Food and Drug Administration (FDA) for use in people with skin diseases that are normally treated with oral corticosteroids, but not yet for Pemphigus vulgaris.

Background

Pemphigus vulgaris (PV) is an autoimmune disease in which the skin is weakened due to the body’s own attack of the molecules (desmosomes) that hold cells together.  The standard treatment of PV is oral (by mouth) or injections of high amounts (doses) of corticosteroids.  This treatment has changed PV from a life-threatening disease to one that can be better treated but not cured.  However, long-term use of such treatments can cause serious side effects, such as bone loss and sugar intolerance as well as making one more vulnerable to the disease.

Study Participation

The study lasts two consecutive days.  On the first day, we will take the participant’s medical and review his or her medical record.  Then, either Clobetasol or a placebo (looks like Clobetasol but does not contain any active medicine) cream will be applied to either of the participant’s forearms.  Neither the study physicians nor his staff will know which topical cream was applied to the participant’s forearms until the end of the study.  The next day, we will use a device that looks like a suction cup with a tube attached to cause a blister to form.  The time that it takes for the participant’s skin to blister will be recorded.  In patients with Pemphigus vulgaris, it should take approximately 30 seconds for this to occur.  It should take about 4 days for blisters to resolve.  We may photograph the participant’s forearms, but we will not include his or her face or any identifying features in the photographs.  The participant’s forearms will also be checked for any side effects.

The participant will be paid for his or her time and travel expenses.  The participant will be paid a total of $40 upon completion of the study.  If the participant is unable to complete this study, the participant will be paid $20 for each of the visits he or she was able to complete.

Enrollment Criteria

  • Patients with Pemphigus vulgaris who are above 18 years of age

Exclusions

  • Pregnant or Nursing women
  • Patients who have used topical medications on their forearms within the past 30 days

Contact Information

If you are interested in participating in this study or have any questions, please contact:

Principal Investigator
Michael Kolodney, M.D.
Assistant Professor of Medicine (Dermatology)
Harbor-UCLA Medical Center
David Geffen School of Medicine at UCLA

Study Coordinator
Sandy Chira
(310) 222-1845
[email protected]

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The P/P Registry has been approved by the Western Institutional Review Board (WIRB) and is actively enrolling participants.

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