ClinicalTrials.gg
Status unknownNCT01870050Updated Jun 5, 2013

Dapsone Prurigo Study

An interventional study of Dapsone gel - verum in Lichen Simples Chronicus and Prurigo, sponsored by Cook County Health. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-05.

Sponsored by Cook County Health · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Lichen Simples Chronicus and Prurigo

Keywords

  • lichen simplex chronicus
  • prurigo
03

In context

Prurigo

38 studies on the registry are indexed under Prurigo; 10 are open to participants now.

This study's planned enrollment of 20 is below the median of 135 across 31 interventional studies indexed under Prurigo.

Browse Prurigo studies →

Lead sponsor

Cook County Health is the lead sponsor of 28 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
      • 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 , willing to use adequate during the study conduct

Exclusion criteria

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, 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 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    dapsone gel - verum

    dapsone gel - verum

    Drug: Dapsone gel - verum

  • Placebo comparator
    dapsone gel - vehicle only

Interventions

06

What researchers measure

Primary outcomes

  1. Pruritus based on visual analogue scale in side to side comparison

    Time frame: 8 weeks

Secondary outcomes

  1. 5 D itch scale in side to side comparison

    Time frame: 8 weeks

07

Study locations

1 site
  • J H Stroger Hospital of Cook County
    Chicago, Illinois 60612, United States
    • Joerg Albrecht, MD · Contactjalbrecht@cookcountyhhs.org · 312-864-4480
    • Joerg Albrecht · Principal investigator
    • Warren Piette, MD · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01870050
Lead sponsor
Cook County Health
Responsible party
Joerg Albrecht (Attending Physician, Cook County Health) — Principal investigator
First posted
Jun 5, 2013
Start date
Sep 2013
Primary completion
Nov 2019 (estimated)
Completion
Nov 2019 (estimated)
Last update
Jun 5, 2013

Study contacts

Joerg Albrecht, MD
Contact
jalbrecht@cookcountyhhs.org
3128644480
Joerg Albrecht, MD
principal investigator · J.H.Stroger Hospital of Cook County

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dapsone Gel

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