Trials Sponsors Conditions Drugs Pricing

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

Interventions

COL-121Drug

75 µg/g COL-121 Ointment

50 µg/g Calcipotriene OintmentDrug

50 µg/g Calcipotriene Ointment

Also known as: Dovonex

50 µg/g Calcipotriene Ointment

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Deltanoid Pharmaceuticals
Industrylead

Study Sites (20)

East Bay Dermatology Medical Group

Fremont, California, 94538, United States

Dermatology Research Associates

Los Angeles, California, 90045, United States

Skin Surgery Medical Group, Inc.

San Diego, California, 92117, United States

Dermatology Specialists, Inc.

Vista, California, 92083, United States

Cherry Creek Research, Inc.

Denver, Colorado, 80209, United States

Longmont Medical Research Network

Longmont, Colorado, 80501, United States

The Savin Center, PC

New Haven, Connecticut, 06511, United States

MeSH Terms

Conditions

Psoriasis

Interventions

calcipotriene

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Michael Graeber, MD
Galderma R&D
STUDY DIRECTOR

Enrollment

321 participants (actual enrollment reported by the registry).

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 2008

Date type not reported

This date has not been verified as actual or estimated.

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.
+3 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (5)

75 µg/g COL-121 Ointment

150 µg/g COL-121 Ointment

300 µg/g COL-121 Ointment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (20)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

50 µg/g Calcipotriene Ointment

Placebo Ointment

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (5)

75 µg/g COL-121 Ointment

150 µg/g COL-121 Ointment

300 µg/g COL-121 Ointment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (20)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

50 µg/g Calcipotriene Ointment

Placebo Ointment

You may not qualify if:

Source record

Locations