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Study of Dose-Effect of COL-121 Ointment in Patients With Plaque-Type Psoriasis

Primary Purpose

Plaque-type Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
COL-121
50 µg/g Calcipotriene Ointment
Placebo
COL-121
COL-121
Sponsored by
Deltanoid Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque-type Psoriasis focused on measuring psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Psoriasis must affect at least 2% and not more than 10% of the subject's body surface area, excluding the face and scalp
  • Subject must have 2 to 4 target plaques on the area to be treated, excluding the face and scalp.
  • Subjects who are women of childbearing potential must have a negative pregnancy test and be non-lactating.
  • Subjects who are women of childbearing potential must utilize one of the following methods of birth control throughout the study: IUD, diaphragm, a condom, a spermicidal gel or foam, oral contraceptives (provided subject has been utilizing this method for at least 4 months prior to Visit 1 and has not changed the brand within this period). Subjects may also participate if they are surgically sterilized, in a monogamous relationship with a sterile partner, or abstain from sexual intercourse during the course of the study.
  • Subjects must be in good general health and free of any disease state or physical condition that, in the investigator's opinion, may interfere with study evaluations or exposes the subject to unacceptable risk by study participation.
  • Subject must be willing and able to apply the study medication as directed, comply with the study instructions, and commit to all the follow-up visits for the duration of the study.
  • Subjects must sign an informed consent form.

Exclusion Criteria:

  • Subjects who have guttate, pustular, erythrodermic or other non-plaque types of psoriasis.
  • Subjects who have spontaneously improving or rapidly deteriorating plaque psoriasis.
  • Subjects who have used systemic immunomodulatory therapy known to affect psoriasis and to typically decrease immune cell populations (e.g., alefacept) within the previous 40 weeks.
  • Subjects who have used any systemic immunomodulatory therapy known to affect psoriasis and to NOT typically decrease immune cell populations (e.g., etanercept) within the previous 16 weeks.
  • Subjects who have used any photo-therapy (including laser), photo-chemotherapy or systemic psoriasis therapy (e.g., systemic corticosteroids, methotrexate, retinoids, cyclosporine) within the previous 12 weeks.
  • Subjects who have had prolonged exposure to natural or artificial sources of ultraviolet radiation within the previous 3 weeks or are intending to have such exposure during the study, thought by the investigator likely to modify the subject's plaque psoriasis.
  • Subjects who have used topical anti-psoriatic therapy (including topical retinoids) on the areas to be evaluated within the previous 2 weeks.
  • Subjects who have used emollients/moisturizers on the areas to be evaluated within the previous 1 day.
  • Subjects who have untreated bacterial, tubercular, fungal or viral lesions of the skin on the areas to be evaluated.
  • Subjects who have known sensitivity to a component of the study medication or to topical or systemic vitamin D.
  • Subjects who have any significant condition such as diseases of the hepatic, renal, endocrine, musculoskeletal, or nervous system, or any gross physical impairment.
  • Subjects who have taken a vitamin D supplement that exceeds 400 IU per day in the previous 30 days.
  • Subjects who have taken a calcium supplement that exceeds 1200 mg per day in the previous 30 days.
  • Subjects who are using lithium or Plaquenil.
  • Subjects who are using beta-blocking medication or thiazide diuretics whose dose has not been stable for at least 12 weeks.
  • Subjects who have a history of hypercalcemia or evidence of vitamin D toxicity.
  • Subjects who are currently being treated for malignancy or have been diagnosed with melanoma within the past 5 years.
  • Subjects who have received any investigational treatment(s) within the previous 30 days.

Sites / Locations

  • East Bay Dermatology Medical Group
  • Dermatology Research Associates
  • Skin Surgery Medical Group, Inc.
  • Dermatology Specialists, Inc.
  • Cherry Creek Research, Inc.
  • Longmont Medical Research Network
  • The Savin Center, PC
  • International Dermatology Research, Inc.
  • MedaPhase, Inc.
  • Dermatology Specialists
  • Michigan Center for Skin Care Research
  • Grekin Skin Institute
  • Academic Dermatology Associates
  • Northwest Cutaneous Research Specialists
  • Philadelphia Institute of Dermatology
  • DermResearch, Inc.
  • Dermatology Associates of San Antonio
  • Dermatology Research Center
  • The Education & Research Foundation, Inc.
  • Premier Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

75 µg/g COL-121 Ointment

150 µg/g COL-121 Ointment

300 µg/g COL-121 Ointment

50 µg/g Calcipotriene Ointment

Placebo Ointment

Arm Description

75 µg/g COL-121 Ointment

150 µg/g COL-121 Ointment

300 µg/g COL-121 Ointment

50 µg/g Calcipotriene Ointment (active control)

Placebo Ointment

Outcomes

Primary Outcome Measures

Physician's Global Assessment

Secondary Outcome Measures

Change from Baseline of PGA score
PGA score is a scale from 0 to 5, with 0=clear and 5=very severe
Change from baseline of Psoriasis Signs Severity (PSS)
Psoriasis Signs Severity (PSS) is the investigator's evaluation of the severity of each of three key signs of psoriasis (erythema, plaque elevation, and scaling). The PSS for a target plaque is the sum of the individual sign scores for that target plaque. The Erythema Severity Scale, Plaque Elevation Severity Scale, and the Scaling Severity Score are each assessed on a scale from 0=clear to 5=very severe. These scores combined = PSS.

Full Information

First Posted
February 20, 2008
Last Updated
April 19, 2011
Sponsor
Deltanoid Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00625326
Brief Title
Study of Dose-Effect of COL-121 Ointment in Patients With Plaque-Type Psoriasis
Official Title
A Phase II Study of the Dose-Effect of COL-121 Ointment in Patients With Plaque-Type Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Deltanoid Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Low doses of topically administered vitamin D analogs have been shown to have an anti-psoriatic effect without the risk of hypercalcemia. Calcipotriol, the most thoroughly studied of the vitamin D analogs, was first approved in Europe in the early 1990s. It has been shown to be comparable or slightly more effective than class II corticosteroid ointments. However, patients had reduced levels of parathyroid hormone; mean serum and urine calcium were increased during treatment and hypercalciuria was observed. These effects were reversible with discontinuation of therapy. Thus, while calcipotriol ointment was shown to be effective, the potential for alterations in calcium homeostasis have limited its use to 100 g of ointment per week (0.5 mg calcipotriol/week). Work has continued on the creation of new vitamin D analogs, such as COL-121, with the intent of eliminating the adverse effects of hypercalcemia and hypercalciuria with a compound that is more stable and more easily administered.
Detailed Description
Psoriasis affects more than 7 million Americans. Plaque-type psoriasis (the most common type of psoriasis) is an inflammatory skin condition with reactive abnormal epidermal differentiation and hyperproliferation. It is characterized by raised, thickened, plaques of erythematous skin covered by a silvery-white scale. Plaque-type psoriasis is most commonly found on the knees, elbows, and scalp but can appear anywhere on the body. While patients with psoriasis may complain of itchiness and discomfort, the psychological effects of the disease are the most debilitating. In a 1998 survey conducted by the National Psoriasis Foundation, it was found that 79% of the psoriasis patients surveyed reported that the disease had a negative impact on their lives and 40% felt frustrated with the ineffectiveness of their current therapies. Although the exact cause of this skin disease is unknown, it is clear that immune-based inflammatory mechanisms initiate an accelerated growth of skin cells. This accelerated growth results in an agglomeration of skin cells on the surface of the epidermis that the body cannot shed. This agglomeration creates the thickened patches of scaly skin characteristic of the disease. Clinical use of systemic vitamin D to treat psoriasis has been limited because of the induction of hypercalcemia. In contrast, low doses of topically administered vitamin D analogs have been shown to have an anti-psoriatic effect without the risk of hypercalcemia. Topical vitamin D analogs have the ability to inhibit the proliferation and promote the differentiation of keratinocytes in psoriatic skin. In addition, vitamin D analogs may also act by inhibiting cytokine production by keratinocytes or lymphocytes. Calcipotriol, the most thoroughly studied of the vitamin D analogs, was first approved in Europe in the early 1990s. It has been shown to be comparable or slightly more effective than class II corticosteroid ointments. In patients with extensive psoriasis, calcipotriol ointment was shown to be effective. However, patients had reduced levels of parathyroid hormone; mean serum and urine calcium were increased during treatment and hypercalciuria was recorded in 3 patients. These effects were reversible with discontinuation of therapy. In a review of the effects on calcium homeostasis, it was noted that calcipotriol (50 µg/g) had no effects on serum or urine calcium when administered at doses of 40-50 g/week and two reports of hypercalcemia at doses of 70-100 g/week. Thus, while calcipotriol ointment was shown to be effective, the potential for alterations in calcium homeostasis have limited its use to 100 g of ointment per week (0.5 mg calcipotriol/week). Subsequently, calcipotriol and tacalcitol, another vitamin D analog, have become first-line therapies in the management of "mild to moderate" psoriasis in several countries in Western Europe, Japan and the USA. Work has continued on the creation of new vitamin D analogs, such as COL-121, with the intent of eliminating the adverse effects of hypercalcemia and hypercalciuria with a compound that is more stable and more easily administered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque-type Psoriasis
Keywords
psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
321 (Actual)

8. Arms, Groups, and Interventions

Arm Title
75 µg/g COL-121 Ointment
Arm Type
Experimental
Arm Description
75 µg/g COL-121 Ointment
Arm Title
150 µg/g COL-121 Ointment
Arm Type
Experimental
Arm Description
150 µg/g COL-121 Ointment
Arm Title
300 µg/g COL-121 Ointment
Arm Type
Experimental
Arm Description
300 µg/g COL-121 Ointment
Arm Title
50 µg/g Calcipotriene Ointment
Arm Type
Active Comparator
Arm Description
50 µg/g Calcipotriene Ointment (active control)
Arm Title
Placebo Ointment
Arm Type
Placebo Comparator
Arm Description
Placebo Ointment
Intervention Type
Drug
Intervention Name(s)
COL-121
Intervention Description
75 µg/g COL-121 Ointment
Intervention Type
Drug
Intervention Name(s)
50 µg/g Calcipotriene Ointment
Other Intervention Name(s)
Dovonex
Intervention Description
50 µg/g Calcipotriene Ointment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
COL-121
Intervention Description
150 µg/g COL-121 Ointment
Intervention Type
Drug
Intervention Name(s)
COL-121
Intervention Description
300 µg/g COL-121 Ointment
Primary Outcome Measure Information:
Title
Physician's Global Assessment
Time Frame
Randomization and Day 84
Secondary Outcome Measure Information:
Title
Change from Baseline of PGA score
Description
PGA score is a scale from 0 to 5, with 0=clear and 5=very severe
Time Frame
Day 0, week 2, 4, 8, 12, and 16
Title
Change from baseline of Psoriasis Signs Severity (PSS)
Description
Psoriasis Signs Severity (PSS) is the investigator's evaluation of the severity of each of three key signs of psoriasis (erythema, plaque elevation, and scaling). The PSS for a target plaque is the sum of the individual sign scores for that target plaque. The Erythema Severity Scale, Plaque Elevation Severity Scale, and the Scaling Severity Score are each assessed on a scale from 0=clear to 5=very severe. These scores combined = PSS.
Time Frame
Day 0, week 2, 4, 8, 12, and 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Psoriasis must affect at least 2% and not more than 10% of the subject's body surface area, excluding the face and scalp Subject must have 2 to 4 target plaques on the area to be treated, excluding the face and scalp. Subjects who are women of childbearing potential must have a negative pregnancy test and be non-lactating. Subjects who are women of childbearing potential must utilize one of the following methods of birth control throughout the study: IUD, diaphragm, a condom, a spermicidal gel or foam, oral contraceptives (provided subject has been utilizing this method for at least 4 months prior to Visit 1 and has not changed the brand within this period). Subjects may also participate if they are surgically sterilized, in a monogamous relationship with a sterile partner, or abstain from sexual intercourse during the course of the study. Subjects must be in good general health and free of any disease state or physical condition that, in the investigator's opinion, may interfere with study evaluations or exposes the subject to unacceptable risk by study participation. Subject must be willing and able to apply the study medication as directed, comply with the study instructions, and commit to all the follow-up visits for the duration of the study. Subjects must sign an informed consent form. Exclusion Criteria: Subjects who have guttate, pustular, erythrodermic or other non-plaque types of psoriasis. Subjects who have spontaneously improving or rapidly deteriorating plaque psoriasis. Subjects who have used systemic immunomodulatory therapy known to affect psoriasis and to typically decrease immune cell populations (e.g., alefacept) within the previous 40 weeks. Subjects who have used any systemic immunomodulatory therapy known to affect psoriasis and to NOT typically decrease immune cell populations (e.g., etanercept) within the previous 16 weeks. Subjects who have used any photo-therapy (including laser), photo-chemotherapy or systemic psoriasis therapy (e.g., systemic corticosteroids, methotrexate, retinoids, cyclosporine) within the previous 12 weeks. Subjects who have had prolonged exposure to natural or artificial sources of ultraviolet radiation within the previous 3 weeks or are intending to have such exposure during the study, thought by the investigator likely to modify the subject's plaque psoriasis. Subjects who have used topical anti-psoriatic therapy (including topical retinoids) on the areas to be evaluated within the previous 2 weeks. Subjects who have used emollients/moisturizers on the areas to be evaluated within the previous 1 day. Subjects who have untreated bacterial, tubercular, fungal or viral lesions of the skin on the areas to be evaluated. Subjects who have known sensitivity to a component of the study medication or to topical or systemic vitamin D. Subjects who have any significant condition such as diseases of the hepatic, renal, endocrine, musculoskeletal, or nervous system, or any gross physical impairment. Subjects who have taken a vitamin D supplement that exceeds 400 IU per day in the previous 30 days. Subjects who have taken a calcium supplement that exceeds 1200 mg per day in the previous 30 days. Subjects who are using lithium or Plaquenil. Subjects who are using beta-blocking medication or thiazide diuretics whose dose has not been stable for at least 12 weeks. Subjects who have a history of hypercalcemia or evidence of vitamin D toxicity. Subjects who are currently being treated for malignancy or have been diagnosed with melanoma within the past 5 years. Subjects who have received any investigational treatment(s) within the previous 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Graeber, MD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
East Bay Dermatology Medical Group
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Skin Surgery Medical Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Dermatology Specialists, Inc.
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Cherry Creek Research, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Longmont Medical Research Network
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
The Savin Center, PC
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
International Dermatology Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
MedaPhase, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Dermatology Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Michigan Center for Skin Care Research
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Grekin Skin Institute
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Northwest Cutaneous Research Specialists
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Philadelphia Institute of Dermatology
City
Flourtown
State/Province
Pennsylvania
ZIP/Postal Code
19034
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Dermatology Associates of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Dermatology Research Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
The Education & Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Dose-Effect of COL-121 Ointment in Patients With Plaque-Type Psoriasis

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