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PsoriasisPhase 2NCT00763555

Efficacy and Safety Study of CD 2027 Spray in Subjects With Plaque-type Psoriasis

A Phase 2 study testing CD 2027 in people with Psoriasis, run by Galderma R&D at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This was a multicenter, randomized, vehicle-controlled, double-blind parallel group study to evaluate the efficacy and safety of CD 2027 Oily Spray applied twice daily for 8 weeks in participants with plaque-type psoriasis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
CD 2027
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
6 sitesin 2 countries
Study dates
Sep 2008to Mar 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Participant has a diagnosis of plaque-type psoriasis up to 20% of body surface area (BSA) involved excluding the scalp, with a Global Severity Score of at least 3 (moderate) at Screening
  • Participant presents with a representative target lesion that is at least 16 cm² in area, is located on the non-bony areas of the skin, has a Scaling Score up to 2 (moderate), has a DSS of at least 4

Who cannot join

  • Other type of psoriasis (other than plaque)
  • Significant abnormal lab findings
  • Hypercalcemia

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Canada4 sites

  • Ultranova Skincare

    Barrie, Ontario, L4M6L2

  • Stratica Medical

    Edmonton, Alberta, T5K1X3

  • North Bay Dermatology Centre

    North Bay, Ontario, P1B3Z7

  • K. Papp Clinical Research, Inc.

    Waterloo, Ontario, N2J1C4

Other trials in Canada

United States2 sites

  • Minnesota Clinical Study Center

    Fridley, Minnesota, 55432

  • Tennessee Clinical Research Center

    Nashville, Tennessee, 37215

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Vehicle-controlled, Efficacy and Safety Study of CD2027 3µg/g Oily Spray Applied Twice Daily for 8 Weeks in Subjects With Plaque-type Psoriasis

This was a multicenter, randomized, vehicle-controlled, double-blind parallel group study to evaluate the efficacy and safety of CD 2027 Oily Spray applied twice daily for 8 weeks in participants with plaque-type psoriasis.

Conditions
Psoriasis
Being tested
CD 2027, Calcitriol Vehicle
Keywords
psoriasis, spray, calcitriol
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD 2027Drug

    Also called Calcitriol

    Participants applied Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks.

  • Calcitriol VehicleDrug

    Participants applied placebo matched to Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks.

Study groups in NCT00763555
Study groupRoleWhat they receive
Calcitriol 3 mcg/g SprayExperimentalNot described
Receives: Drug: CD 2027
Calcitriol VehiclePlacebo comparatorNot described
Receives: Drug: Calcitriol Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Success Rate 1 (SR1) at Week 8

    Success Rate 1 was defined as percentage of participants who achieved at least 2-grade improvement from Baseline on Global Severity Score (GSS) at Week 8. GSS is a 5-point scale which ranges from 0-4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).

    Measured: Week 8

  2. Percentage of Participants With Success Rate 2 (SR2) at Week 8

    Success Rate 2 was defined as percentage of participants who achieved "clear" or "almost clear" on GSS at Week 8. GSS is a 5-point scale which ranges from 0-4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).

    Measured: Week 8

  3. Change From Baseline in Dermatologic Sum Score (DSS) at Week 8

    DSS is the sum of all the individual score of evaluated target lesion that includes plaque elevation (abnormal thickness of the psoriasis lesion), erythema (abnormal redness of the skin), and scaling (shedding of the stratum corneum). Each individual parameters evaluated the affected area by using a 5-point scale ranging from 0 to 4, that is, 0 = None; 1 = Mild; 2 = Moderate; 3 = Severe and 4 =Very severe, where higher score indicated worst condition. All missing values were imputed by last observation carried forward (LOCF). The total score of each parameter ranges from 0-12, where higher score indicated worst condition.

    Measured: Baseline, Week 8

  4. Percentage of Participants With at Least 1-Grade Improvement From Baseline in Erythema, Scaling and Plaque Elevation

    Erythema (abnormal redness of skin) score is a 5-point scale: 0=None (No detectable erythema. Skin of normal color); 1=Mild (Slight pinkness present); 2=Moderate (Definite redness, easily recognized); 3=Severe (Intense redness) and 4=Severe (Very Intense redness). Scaling (shedding of stratum corneum) score is a 5- point scale: 0=None (No shedding); 1=Mild (Barely perceptible shedding, noticeable only on light scratching or rubbing); 2=Moderate (Obvious but not profuse shedding); 3=Severe (heavy scale production) and 4=Very severe (very thick scales). Plaque elevation (abnormal thickness of psoriasis lesion) score was a 5- point scale: 0=None (Normal skin thickness. No elevation of skin); 1=Mild (Barely perceptible elevation (by touching) of psoriasis plaques); 2=Moderate (Obvious elevation above normal skin level; moderate thickening); 3=Severe (definite thick elevation above normal skin level) and 4=Severe (Very thick elevation).

    Measured: Baseline, Week 8

Secondary outcomes (12)

  1. Number of Participants With Adverse Events (AEs)

    AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

    Measured: up to Week 8

  2. Percentage of Participants With a Local Tolerability Score Worse Than Baseline Score

    Local tolerability skin assessments were performed by the investigator and based on 5-point scale which ranges from 0 to 4. 0 = none (no evidence of local intolerance); 1=mild (minimal erythema and/or edema, slight glazed appearance); 2 = moderate (definite erythema and/or edema with peeling and/or cracking but needs no adaptation of posology); 3 = severe (erythema, edema glazing with fissures, few vesicles or papules) and 4 = very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions). Higher grades indicated worsening of condition. Percentage of participants with increase in score by Week 8 from baseline has been presented here, where the row titles indicate participant's new scores by Week 8.

    Measured: up to Week 8

  3. Change From Baseline in Calcitriol Plasma Levels

    Change from baseline in calcitriol plasma levels were reported.

    Measured: Baseline, Week 8

  4. Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin

    Change from baseline in serum calcium homeostasis parameter (Albumin) were reported.

    Measured: Baseline, Week 8

  5. Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin-adjusted Calcium

    Change from baseline in serum calcium homeostasis parameter (Albumin-adjusted calcium) were reported.

    Measured: Baseline, Week 8

  6. Change From Baseline in Serum Calcium Homeostasis Parameter: Calcium

    Change from baseline in serum calcium homeostasis parameter (Calcium) were reported.

    Measured: Baseline, Week 8

  7. Change From Baseline in Serum Calcium Homeostasis Parameter: Phosphorus

    Change from baseline in serum calcium homeostasis parameter (Phosphorus) were reported.

    Measured: Baseline, Week 8

  8. Change From Baseline in Serum Calcium Homeostasis Parameter: Parathyroid Hormone (PTH) Intact

    Change from baseline in serum calcium homeostasis parameter (PTH intact) were reported.

    Measured: Baseline, Week 8

  9. Change From Baseline in Blood Chemistry: Alkaline Phosphatase, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)

    Change from baseline in Blood Chemistry: Alkaline Phosphatase, AST and ALT were reported.

    Measured: Baseline, Week 8

  10. Change From Baseline in Blood Chemistry: Bilirubin Direct, Bilirubin Total, Blood Urea Nitrogen (BUN) and Creatinine

    Change from baseline in Blood Chemistry: Bilirubin Direct, Bilirubin Total, BUN and Creatinine were reported.

    Measured: Baseline, Week 8

  11. Change From Baseline in Vital Sign Parameter: Heart Rate

    Change from baseline in vital sign parameter: heart rate was reported.

    Measured: Baseline, Week 8

  12. Change From Baseline in Vital Sign Parameter: Systolic Blood Pressure and Diastolic Blood Pressure

    Change from baseline in vital sign parameter: Systolic Blood Pressure and Diastolic Blood Pressure was reported.

    Measured: Baseline, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionJan 2009
  4. Study completionMar 2009

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00763555
Sponsor's protocol ID
RD.06.SPR.18119
Status last verified
Apr 2022
First submitted
30 Sep 2008
Last updated
23 Aug 2022

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CD 2027 in people with Psoriasis, run by Galderma R&D at 6 sites in 2 countries.

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 2 inclusion and 3 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 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada, 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?

Yes. Results are posted in the registry (first posted 23 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Success Rate 1 (SR1) at Week 8 (time frame: Week 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00763555.

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 23 Aug 2022.

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