Dapsone Prurigo Study

A Double-blind, Randomized, Parallel-group, Side-by-side Single-center Study Comparing a Topical Steroid / Vehicle Combination to a Topical Steroid / Topical Dapsone Combination in Patients With Lichen Simplex Chronicus and/or Prurigo Nodularis

Principal aim of this study is to assess whether a combination of topical dapsone and clobetasol as a topical steroid is superior to clobetasol alone as treatment of prurigo nodularis or lichen simplex chronicus in a side to side comparison. The study is primarily exploratory and essentially meant to inform the sponsor whether further development of a combination treatment formulation is warranted

Study Overview

• Status: Unknown
• Conditions: Lichen Simples Chronicus and Prurigo
• Intervention / Treatment: Drug: Dapsone gel - verum

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joerg Albrecht, MD; Phone Number: 3128644480; Email: jalbrecht@cookcountyhhs.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • J H Stroger Hospital of Cook County
      • Contact: Joerg Albrecht, MD; Phone Number: 312-864-4480; Email: jalbrecht@cookcountyhhs.org
      • Principal Investigator: Joerg Albrecht
      • Sub-Investigator: Warren Piette, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Active prurigo nodularis or lichen simplex chronicus - diagnosed by clinical exam

  • For lichen simplex chronicus patients: Severity of maximum pruritus in the last 24 hrs at least 5 out of 10 on a visual analogue scale.
  • For prurigo nodularis patients: Excoriations or signs of other scratch related activity at presentation to demonstrate active disease
  • Symmetrical disease/excoriations allowing for a side-by-side comparison (eg, bilateral lichen simplex chronicus or bilateral prurigo nodularis) - genitals, face, axillae or neck cannot be used for side-to-side comparison
  • Willing to refrain from use of all other topical medications in the treatment areas.
  • Able and willing to provide written informed consent
  • Willing and able to understand and comply with the requirements of the study, apply the treatment combinations as instructs, attend required study visits, comply with study prohibitions and able to complete the study.
  • Male or non-preganant, non-lactating female between 18 and 75 years of age, inclusive
  • For females of child-bearing potential, willing to use adequate birth control during the study conduct

Exclusion Criteria:

• • History of non-compliance with follow up visits

  • Should we exclude failure to certain treatments as an exclusion criterion? Patients who failed oral dapsone should be excluded
  • Presence of any skin condition on the treatment areas that would interfere with the diagnosis or assessment of active lichen simplex chronicus and/or prurigo nodularis (eg, rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis or bacterial folliculitis)
  • Excessive hair in the treatment area that would interfere with diagnosis or assessment of lichen simplex chronicus and/or prurigo nodularis
  • History of hypersensitivity or allergy to topical steroids, dapsone, or any other treatment product components
  • Use of tanning booths, sunbathing or excessive exposure to the sun during the study
  • Consumes excessive amount of alcohol, abuses drugs, or has any condition that would compromise compliance with this protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dapsone gel - verum	Drug: Dapsone gel - verum; Other Names: aczone gel
Placebo Comparator: dapsone gel - vehicle only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pruritus based on visual analogue scale in side to side comparison	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
5 D itch scale in side to side comparison	8 weeks

Collaborators and Investigators

• Sponsor: John H. Stroger Hospital
• Investigators: Principal Investigator: Joerg Albrecht, MD, J.H.Stroger Hospital of Cook County

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: June 3, 2013
• First Submitted That Met QC Criteria: June 4, 2013
• First Posted (Estimate): June 5, 2013

Study Record Updates

• Last Update Posted (Estimate): June 5, 2013
• Last Update Submitted That Met QC Criteria: June 4, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: lichen simplex chronicus; prurigo
• Additional Relevant MeSH Terms: Skin Diseases; Prurigo; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Dapsone
• Other Study ID Numbers: Cookderm 01