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

NCT00625326 | Completed Phase 2

• 1 other identifier: COL-121-PSOR-201
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 20

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.

Conditions

Plaque-type Psoriasis

Keywords

psoriasis

Outcome Measures

Primary Outcomes (1)

• Physician's Global Assessment

  Randomization and Day 84

Secondary Outcomes (2)

• Change from Baseline of PGA score

  Day 0, week 2, 4, 8, 12, and 16

• Change from baseline of Psoriasis Signs Severity (PSS)

  Day 0, week 2, 4, 8, 12, and 16

Study Arms (5)

75 µg/g COL-121 Ointment

EXPERIMENTAL

75 µg/g COL-121 Ointment

Drug: COL-121

150 µg/g COL-121 Ointment

EXPERIMENTAL

150 µg/g COL-121 Ointment

Drug: COL-121

300 µg/g COL-121 Ointment

EXPERIMENTAL

300 µg/g COL-121 Ointment

Drug: COL-121

50 µg/g Calcipotriene Ointment

ACTIVE COMPARATOR

50 µg/g Calcipotriene Ointment (active control)

Drug: 50 µg/g Calcipotriene Ointment

Placebo Ointment

PLACEBO COMPARATOR

Placebo Ointment

Drug: Placebo

Interventions

COL-121 DRUG

75 µg/g COL-121 Ointment

75 µg/g COL-121 Ointment

50 µg/g Calcipotriene Ointment DRUG

50 µg/g Calcipotriene Ointment

Also known as: Dovonex

50 µg/g Calcipotriene Ointment

Placebo DRUG

Placebo

Placebo Ointment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deltanoid Pharmaceuticals: lead

Study Sites (20)

East Bay Dermatology Medical Group

Fremont, California, 94538, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Skin Surgery Medical Group, Inc.

San Diego, California, 92117, United States

Location

Dermatology Specialists, Inc.

Vista, California, 92083, United States

Location

Cherry Creek Research, Inc.

Denver, Colorado, 80209, United States

Location

Longmont Medical Research Network

Longmont, Colorado, 80501, United States

Location

The Savin Center, PC

New Haven, Connecticut, 06511, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

MedaPhase, Inc.

Newnan, Georgia, 30263, United States

Location

Dermatology Specialists

Louisville, Kentucky, 40202, United States

Location

Michigan Center for Skin Care Research

Clinton Township, Michigan, 48038, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Northwest Cutaneous Research Specialists

Portland, Oregon, 97210, United States

Location

Philadelphia Institute of Dermatology

Flourtown, Pennsylvania, 19034, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

Dermatology Associates of San Antonio

San Antonio, Texas, 78258, United States

Location

Dermatology Research Center

Salt Lake City, Utah, 84124, United States

Location

The Education & Research Foundation, Inc.

Lynchburg, Virginia, 24501, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

calcipotriene

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Graeber, MD

  Galderma R&D

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: February 28, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2009
• Last Updated: April 27, 2011

Record last verified: 2011-04

Locations

US (20)