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

NCT01714544 | Completed Phase 4 Results

• 1 other identifier: CDC1201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Investigator's Global Assessment (IGA)

  The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1).

  28 days

Study Arms (1)

Cloderm Cream

EXPERIMENTAL

Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days

Drug: Cloderm Cream

Interventions

Cloderm Cream DRUG

Cloderm Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Promius Pharma, LLC: lead

Study Sites (5)

Radiant Research, Inc.

Cincinnati, Ohio, 45249, United States

Location

Oregon Medical Research

Portland, Oregon, 97223, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Madison Skin and Research, Inc.

Madison, Wisconsin, 53719, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Director Clinical Operations
• Organization: Promius Pharma

jfraser@drreddys.com

609-282-1404

Study Officials

• Joanne M Fraser, PhD

  Promius Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2012
• First Posted: October 26, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Last Updated: July 23, 2014
• Results First Posted: July 23, 2014

Record last verified: 2014-06

Locations

US (5)