PsoriasisPhase 4NCT01714544
Study of the Efficacy of Cloderm® Cream in the Treatment of Moderate Plaque Psoriasis
A Phase 4 study testing Cloderm Cream in people with Psoriasis, run by Promius Pharma, LLC at 5 sites in United States.
Trial summary
The purpose of this study is to determine whether Cloderm Cream is effective for topical treatment of moderate psoriasis over 28 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Cloderm Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2012to Mar 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject understands the study procedures and agrees to participate by giving written informed consent.
- Subjects must be at least 18 years of age.
- Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
- Subjects with psoriasis involving 2 to 20% BSA, not including the face, scalp and intertriginous areas.
- Subjects must have an IGA Grade of 3 at the Baseline Visit.
- Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (Visit 2) (test will have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) and practice a reliable method of contraception or remain sexually inactive throughout the study.
- All women of childbearing potential must be willing to undergo a urine pregnancy test at Visit 2 (Day 0), at Visit 4 (Day 14), and at Visit 5 (Day 28).
- Subjects must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).
Who cannot join
- Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
- Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
- Presence of pigmentation, extensive scarring, pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.
- History of psoriasis unresponsive to topical treatments.
- History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
- Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, or alefacept).
Show all 14Show fewer
- Have received treatment for any type of cancer within 5 years of the Baseline Visit except for non-melanoma skin cancer and cervical cancer (in situ) are allowed within 1 year of the Baseline Visit.
- Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).
- Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Note: Inhaled, intraocular and intranasal steroids are allowed.
- Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.
- Subjects with known hypersensitivity to clocortolone pivalate or any component of Cloderm Cream.
- Subjects who have participated in a study of an investigational drug 60 days prior to the Baseline Visit.
- Subjects unable to comply with study requirements.
- Female subjects who are pregnant (or planning to become pregnant) or breast-feeding.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
DermResearch, Inc.
Austin, Texas, 78759
Radiant Research, Inc.
Cincinnati, Ohio, 45249
Research Across America
Dallas, Texas, 75234
Madison Skin and Research, Inc.
Madison, Wisconsin, 53719
Oregon Medical Research
Portland, Oregon, 97223
About this study
Official title: An Open-Label, Multicenter Study of the Efficacy of Cloderm® Cream (Clocortolone Pivalate, 0.1%) in the Treatment of Moderate Plaque Psoriasis for 28 Days
The purpose of this study is to determine whether Cloderm Cream is effective for topical treatment of moderate psoriasis over 28 days.
Read the detailed description
The objective of this study is to estimate the efficacy of Cloderm Cream for topical treatment of moderate plaque psoriasis over 28 days using current standards for evaluation.
- Conditions
- Psoriasis
- Being tested
- Cloderm Cream
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cloderm CreamDrug
| Study group | Role | What they receive |
|---|---|---|
| Cloderm Cream | Experimental | Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days Receives: Drug: Cloderm Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment (IGA)
The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promius Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanne M Fraser, PhD, Study director, Promius Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714544
- Sponsor's protocol ID
- CDC1201
- Status last verified
- Jun 2014
- First submitted
- 23 Oct 2012
- Last updated
- 23 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Study of the Efficacy of Cloderm® Cream (Clocortolone Pivalate, 0.1%) in the Treatment of Moderate Plaque Psoriasis for 28 Days
- ClinicalTrials.gov ID
- NCT01714544
- Acronym / sponsor ID
- CDC1201
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Promius Pharma, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Posted 23 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Cloderm Cream is effective for topical treatment of moderate psoriasis over 28 days.
Detailed description
The objective of this study is to estimate the efficacy of Cloderm Cream for topical treatment of moderate plaque psoriasis over 28 days using current standards for evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cloderm Cream | Experimental | Drug: Cloderm CreamCloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject understands the study procedures and agrees to participate by giving written informed consent.
- Subjects must be at least 18 years of age.
- Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
- Subjects with psoriasis involving 2 to 20% BSA, not including the face, scalp and intertriginous areas.
- Subjects must have an IGA Grade of 3 at the Baseline Visit.
Key exclusion criteria (14 listed)
- Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
- Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
- Presence of pigmentation, extensive scarring, pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.
- History of psoriasis unresponsive to topical treatments.
- History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
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 |
|---|---|---|
| Cloderm Cream | Drug | Cloderm Cream |
Primary outcome
Investigator's Global Assessment (IGA)
Time frame: 28 days
The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joanne M Fraser, PhD study director
Promius Pharma
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cloderm Cream in people with Psoriasis, run by Promius Pharma, LLC at 5 sites 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 8 inclusion and 14 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: finished, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator's Global Assessment (IGA) (time frame: 28 days). 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 23 Jul 2014.