Dapsone Prurigo Study

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Lichen Simples Chronicus and Prurigo

Intervention / Treatment
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* Drug: Dapsone gel - verum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dapsone gel - verum<br>dapsone gel - verum | Drug: Dapsone gel - verum<br> <br> * Other names: aczone gel;|
| Placebo Comparator: dapsone gel - vehicle only<br> | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prurigo, lichen simplex chronicus