Study of the Efficacy of Cloderm® Cream in the Treatment of Moderate Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Promius Pharma, LLC
ClinicalTrials.gov Identifier:
NCT01714544
First received: October 23, 2012
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to determine whether Cloderm Cream is effective for topical treatment of moderate psoriasis over 28 days.


Condition Intervention Phase
Psoriasis
Drug: Cloderm Cream
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Promius Pharma, LLC:

Primary Outcome Measures:
  • Investigator's Global Assessment (IGA) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1).


Enrollment: 60
Study Start Date: October 2012
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cloderm Cream
Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days
Drug: Cloderm Cream
Other Name: Cloderm Cream

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714544

Locations
United States, Ohio
Radiant Research, Inc.
Cincinnati, Ohio, United States, 45249
United States, Oregon
Oregon Medical Research
Portland, Oregon, United States, 97223
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
Research Across America
Dallas, Texas, United States, 75234
United States, Wisconsin
Madison Skin and Research, Inc.
Madison, Wisconsin, United States, 53719
Sponsors and Collaborators
Promius Pharma, LLC
Investigators
Study Director: Joanne M Fraser, PhD Promius Pharma
  More Information

No publications provided

Responsible Party: Promius Pharma, LLC
ClinicalTrials.gov Identifier: NCT01714544     History of Changes
Other Study ID Numbers: CDC1201
Study First Received: October 23, 2012
Results First Received: June 25, 2014
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Clocortolone
Clocortolone pivalate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014