Dapsone Prurigo Study

NCT ID: NCT01870050

Last Updated: 2013-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2019-11-30

Brief 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

Conditions

Lichen Simples Chronicus and Prurigo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

dapsone gel - verum

dapsone gel - verum

Group Type: ACTIVE_COMPARATOR

Dapsone gel - verum

Intervention Type: DRUG

dapsone gel - vehicle only

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Dapsone gel - verum

Intervention Type: DRUG

Other Intervention Names

aczone gel

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cook County Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Joerg Albrecht

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joerg Albrecht, MD

Role: PRINCIPAL_INVESTIGATOR

J.H.Stroger Hospital of Cook County

Locations

J H Stroger Hospital of Cook County

Chicago, Illinois, United States

Countries

United States

Central Contacts

Joerg Albrecht, MD

Role: CONTACT

jalbrecht@cookcountyhhs.org

3128644480

Facility Contacts

Joerg Albrecht, MD

Role: primary

jalbrecht@cookcountyhhs.org

312-864-4480

Other Identifiers

Cookderm 01

Identifier Type: -

Identifier Source: org_study_id