Plaque-type PsoriasisPhase 2NCT00625326
Study of Dose-Effect of COL-121 Ointment in Patients With Plaque-Type Psoriasis
A Phase 2 study testing COL-121 and 50 µg/g Calcipotriene Ointment in people with Plaque-type Psoriasis, run by Deltanoid Pharmaceuticals at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque-type Psoriasis
- What is being tested?
- COL-121 and 50 µg/g Calcipotriene Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- 20 sitesUnited States
- Study dates
- Jan 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DermResearch, Inc.
Austin, Texas, 78759
Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038
Cherry Creek Research, Inc.
Denver, Colorado, 80209
Philadelphia Institute of Dermatology
Flourtown, Pennsylvania, 19034
East Bay Dermatology Medical Group
Fremont, California, 94538
Longmont Medical Research Network
Longmont, Colorado, 80501
Dermatology Research Associates
Los Angeles, California, 90045
Dermatology Specialists
Louisville, Kentucky, 40202
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501
International Dermatology Research, Inc.
Miami, Florida, 33144
The Savin Center, PC
New Haven, Connecticut, 06511
MedaPhase, Inc.
Newnan, Georgia, 30263
Northwest Cutaneous Research Specialists
Portland, Oregon, 97210
Dermatology Research Center
Salt Lake City, Utah, 84124
Dermatology Associates of San Antonio
San Antonio, Texas, 78258
Skin Surgery Medical Group, Inc.
San Diego, California, 92117
Premier Clinical Research
Spokane, Washington, 99204
Dermatology Specialists, Inc.
Vista, California, 92083
Grekin Skin Institute
Warren, Michigan, 48088
About this study
Official title: A Phase II Study of the Dose-Effect of COL-121 Ointment in Patients With Plaque-Type Psoriasis
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.
Read the 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.
- Conditions
- Plaque-type Psoriasis
- Being tested
- COL-121, 50 µg/g Calcipotriene Ointment, Placebo
- Keywords
- psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COL-121Drug
75 µg/g COL-121 Ointment
50 µg/g Calcipotriene OintmentDrug
Also called Dovonex
50 µg/g Calcipotriene Ointment
PlaceboDrug
Placebo
COL-121Drug
150 µg/g COL-121 Ointment
COL-121Drug
300 µg/g COL-121 Ointment
| Study group | Role | What they receive |
|---|---|---|
| 75 µg/g COL-121 Ointment | Experimental | 75 µg/g COL-121 Ointment Receives: Drug: COL-121 |
| 150 µg/g COL-121 Ointment | Experimental | 150 µg/g COL-121 Ointment Receives: Drug: COL-121 |
| 300 µg/g COL-121 Ointment | Experimental | 300 µg/g COL-121 Ointment Receives: Drug: COL-121 |
| 50 µg/g Calcipotriene Ointment | Active comparator | 50 µg/g Calcipotriene Ointment (active control) Receives: Drug: 50 µg/g Calcipotriene Ointment |
| Placebo Ointment | Placebo comparator | Placebo Ointment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's Global Assessment
Measured: Randomization and Day 84
Secondary outcomes (2)
Change from Baseline of PGA score
PGA score is a scale from 0 to 5, with 0=clear and 5=very severe
Measured: Day 0, week 2, 4, 8, 12, and 16
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.
Measured: Day 0, week 2, 4, 8, 12, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque-type PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deltanoid Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Graeber, MD, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625326
- Sponsor's protocol ID
- COL-121-PSOR-201
- Status last verified
- Apr 2011
- First submitted
- 20 Feb 2008
- Last updated
- 27 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Dose-Effect of COL-121 Ointment in Patients With Plaque-Type Psoriasis
- ClinicalTrials.gov ID
- NCT00625326
- Acronym / sponsor ID
- COL-121-PSOR-201
- Conditions
- Plaque-type Psoriasis
- Keywords
- psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Deltanoid PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 75 µg/g COL-121 Ointment | Experimental | Drug: COL-12175 µg/g COL-121 Ointment |
| 150 µg/g COL-121 Ointment | Experimental | Drug: COL-121150 µg/g COL-121 Ointment |
| 300 µg/g COL-121 Ointment | Experimental | Drug: COL-121300 µg/g COL-121 Ointment |
| 50 µg/g Calcipotriene Ointment | Active comparator | Drug: 50 µg/g Calcipotriene Ointment50 µg/g Calcipotriene Ointment (active control) |
| Placebo Ointment | Placebo comparator | Drug: PlaceboPlacebo Ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COL-12175 µg/g COL-121 Ointment | Drug | 75 µg/g COL-121 Ointment |
| 50 µg/g Calcipotriene OintmentAlso: Dovonex50 µg/g Calcipotriene Ointment | Drug | 50 µg/g Calcipotriene Ointment |
| PlaceboPlacebo | Drug | Placebo Ointment |
| COL-121150 µg/g COL-121 Ointment | Drug | 150 µg/g COL-121 Ointment |
| COL-121300 µg/g COL-121 Ointment | Drug | 300 µg/g COL-121 Ointment |
Primary outcome
Physician's Global Assessment
Time frame: Randomization and Day 84
2 secondary outcomes
Change from Baseline of PGA score
Time frame: Day 0, week 2, 4, 8, 12, and 16
Change from baseline of Psoriasis Signs Severity (PSS)
Time frame: Day 0, week 2, 4, 8, 12, and 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Graeber, MD study director
Galderma R&D
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COL-121 and 50 µg/g Calcipotriene Ointment in people with Plaque-type Psoriasis, run by Deltanoid Pharmaceuticals at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician's Global Assessment (time frame: Randomization and Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2011.