Lichen Simples Chronicus and PrurigoNCT01870050
Dapsone Prurigo Study
A study testing Dapsone gel - verum in people with Lichen Simples Chronicus and Prurigo, run by Cook County Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lichen Simples Chronicus and Prurigo
- What is being tested?
- Dapsone gel - verum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
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- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
United States1 site
J H Stroger Hospital of Cook County
Chicago, Illinois, 60612
Joerg Albrecht, MD, 312-864-4480, jalbrecht@cookcountyhhs.org
Joerg Albrecht
About this study
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
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
- Being tested
- Dapsone gel - verum
- Keywords
- lichen simplex chronicus, prurigo
- Medical subject headings
- Prurigo, Neurodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapsone gel - verumDrug
Also called aczone gel
| Study group | Role | What they receive |
|---|---|---|
| dapsone gel - verum | Active comparator | dapsone gel - verum Receives: Drug: Dapsone gel - verum |
| dapsone gel - vehicle only | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus based on visual analogue scale in side to side comparison
Measured: 8 weeks
Secondary outcomes (1)
5 D itch scale in side to side comparison
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen Simples Chronicus and PrurigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Joerg Albrecht, Cook County Health
- Investigators
- Joerg Albrecht, MD, Principal investigator, J.H.Stroger Hospital of Cook County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870050
- Sponsor's protocol ID
- Cookderm 01
- Status last verified
- Jun 2013
- First submitted
- 3 Jun 2013
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01870050
- Acronym / sponsor ID
- Cookderm 01
- Conditions
- Lichen Simples Chronicus and Prurigo
- Keywords
- lichen simplex chronicus, prurigo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cook County HealthOther government
- Study start
- Sep 2013
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dapsone gel - verum | Active comparator | Drug: Dapsone gel - verumdapsone gel - verum |
| dapsone gel - vehicle only | Placebo comparator | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- • Active prurigo nodularis or lichen simplex chronicus - diagnosed by clinical exam
Key exclusion criteria (7 listed)
- • History of non-compliance with follow up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapsone gel - verumAlso: aczone gel | Drug | dapsone gel - verum |
Primary outcome
Pruritus based on visual analogue scale in side to side comparison
Time frame: 8 weeks
1 secondary outcome
5 D itch scale in side to side comparison
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joerg Albrecht, MD principal investigator
J.H.Stroger Hospital of Cook County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dapsone gel - verum in people with Lichen Simples Chronicus and Prurigo, run by Cook County Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joerg Albrecht, MD (3128644480, jalbrecht@cookcountyhhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pruritus based on visual analogue scale in side to side comparison (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013; AzTrials last refreshed its copy on 28 Oct 2026.