Plaque Psoriasis
Conditions
Brief summary
The purpose of this study is to compare the safety, efficacy and calcium metabolism of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis.
Interventions
DRUGplacebo comparator
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Male or female 2 to 12 years of age * Clinical diagnosis of stable mild to moderate plaque psoriasis
Exclusion criteria
* Other forms of psoriasis * Hypercalcemia * Past history of kidney stones * Vitamin D deficiency * Other concomitant dermatological disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of Investigator's Global Assessment (IGA) | Baseline to Week 8 | The number of subjects with a minimum improvement of 2 grades from baseline in the IGA score and a severity rating of 0 (clear) of 1 (almost clear) at Week 8 (LOCF). The IGA was evaluated at each visit on the following 0 to 4 point scale: 0 - Clear: No signs of psoriasis except for residual hypopigmentation / hyperpigmentation 1. \- Almost Clear: Just perceptible erythema, no induration, and no scaling 2. \- Mild: Mild erythema, no induration, and mild or no scaling 3. \- Moderate: Moderate erythema, mild induration, and mild or no scaling 4. \- Severe: Severe erythema, moderate to severe induration, and scaling of any degree |
Countries
Belgium, Canada, Germany, Hungary, Italy, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Calcitriol Ointment Calcitriol 3 mcg/g Ointment | 8 |
| Placebo Placebo comparator | 11 |
| Total | 19 |
Baseline characteristics
| Characteristic | Calcitriol Ointment | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 9.6 years STANDARD_DEVIATION 1.8 | 9.8 years STANDARD_DEVIATION 1.8 | 9.7 years STANDARD_DEVIATION 1.8 |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 8 | 8 / 11 |
| serious Total, serious adverse events | 0 / 8 | 0 / 11 |
Outcome results
Primary
Success of Investigator's Global Assessment (IGA)
The number of subjects with a minimum improvement of 2 grades from baseline in the IGA score and a severity rating of 0 (clear) of 1 (almost clear) at Week 8 (LOCF). The IGA was evaluated at each visit on the following 0 to 4 point scale: 0 - Clear: No signs of psoriasis except for residual hypopigmentation / hyperpigmentation 1. \- Almost Clear: Just perceptible erythema, no induration, and no scaling 2. \- Mild: Mild erythema, no induration, and mild or no scaling 3. \- Moderate: Moderate erythema, mild induration, and mild or no scaling 4. \- Severe: Severe erythema, moderate to severe induration, and scaling of any degree
Time frame: Baseline to Week 8
Population: ITT: All randomized subjects to whom study medication was dispensed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Calcitriol Ointment | Success of Investigator's Global Assessment (IGA) | 3 Participants |
| Placebo | Success of Investigator's Global Assessment (IGA) | 7 Participants |