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Dapsone Prurigo Study

Information source: John H. Stroger Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lichen Simples Chronicus and Prurigo

Intervention: Dapsone gel - verum (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: John H. Stroger Hospital

Official(s) and/or principal investigator(s):
Joerg Albrecht, MD, Principal Investigator, Affiliation: J.H.Stroger Hospital of Cook County

Overall contact:
Joerg Albrecht, MD, Phone: 3128644480, Email: jalbrecht@cookcountyhhs.org

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pruritus based on visual analogue scale in side to side comparison

Secondary outcome: 5 D itch scale in side to side comparison

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Joerg Albrecht, MD, Phone: 3128644480, Email: jalbrecht@cookcountyhhs.org

J H Stroger Hospital of Cook County, Chicago, Illinois 60612, United States; Not yet recruiting
Joerg Albrecht, MD, Phone: 312-864-4480, Email: jalbrecht@cookcountyhhs.org
Joerg Albrecht, Principal Investigator
Warren Piette, MD, Sub-Investigator
Additional Information

Starting date: September 2013
Last updated: June 4, 2013

Page last updated: August 23, 2015

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