Psoriasis
Conditions
Brief summary
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.
Interventions
DRUGCloderm Cream
Sponsors
Promius Pharma, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject understands the study procedures and agrees to participate by giving written informed consent. 2. Subjects must be at least 18 years of age. 3. Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis. 4. Subjects with psoriasis involving 2 to 20% BSA, not including the face, scalp and intertriginous areas. 5. Subjects must have an IGA Grade of 3 at the Baseline Visit. 6. 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). 7. 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).
Exclusion criteria
1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis. 2. Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis). 3. Presence of pigmentation, extensive scarring, pigmented lesions or sunburn which could interfere with the rating of efficacy parameters. 4. History of psoriasis unresponsive to topical treatments. 5. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state. 6. Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, or alefacept). 7. 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. 8. 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). 9. 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. 10. 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. 11. Subjects with known hypersensitivity to clocortolone pivalate or any component of Cloderm Cream. 12. Subjects who have participated in a study of an investigational drug 60 days prior to the Baseline Visit. 13. Subjects unable to comply with study requirements. 14. Female subjects who are pregnant (or planning to become pregnant) or breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Global Assessment (IGA) | 28 days | The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cloderm Cream Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days
Cloderm Cream | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Cloderm Cream |
|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 60 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 55 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Investigator's Global Assessment (IGA)
The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1).
Time frame: 28 days
Population: Intent to treat population, with LOCF for missing data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cloderm Cream | Investigator's Global Assessment (IGA) | 15 percentage of subjects |