Psoriasis Vulgaris
Conditions
Brief summary
The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque psoriasis.
Interventions
DRUGCalcitriol
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Male or female 2 to 16 years and 11 months 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 |
|---|---|---|
| Change From Screening in Serum Albumin Levels at Week 4 | Screening, Week 4 | Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported. |
| Change From Screening in Serum Albumin Levels at Week 8 | Screening, Week 8 | Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 8 were reported. |
| Change From Screening in Serum Albumin Levels at Week 12 | Screening, Week 12 | Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 12 were reported. |
| Change From Screening in Serum Albumin Levels at Week 20 | Screening, Week 20 | Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 20 were reported. |
| Change From Screening in Serum Albumin Levels at Week 26 | Screening, Week 26 | Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 26 were reported. |
| Change From Screening in Serum Albumin Levels at Week 30 (Follow-up) | Screening, Week 30 (Follow-up) | Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 30 were reported. |
| Change From Screening in Urine Calcium/Creatinine Ratio at Week 12 | Screening, Week 12 | Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 12 were reported. |
| Change From Screening in Urine Calcium/Creatinine Ratio at Week 26 | Screening, Week 26 | Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 26 were reported. |
| Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up) | Screening, Week 30 (Follow-up) | Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 30 were reported. |
| Change From Screening in Serum Phosphate Levels at Week 4 | Screening, Week 4 | Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 4 were reported. |
| Change From Screening in Serum Phosphate Levels at Week 12 | Screening, Week 12 | Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 12 were reported. |
| Change From Screening in Serum Phosphate Levels at Week 20 | Screening, Week 20 | Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 20 were reported. |
| Change From Screening in Serum Phosphate Levels at Week 26 | Screening, Week 26 | Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 26 were reported. |
| Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up) | Screening, Week 30 (Follow-up) | Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 30 were reported. |
| Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4 | Screening, Week 4 | Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 4 were reported. |
| Change From Screening in Serum Parathyroid Hormone Levels at Week 8 | Screening, Week 8 | Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 8 were reported. |
| Change From Screening in Serum Parathyroid Hormone Levels at Week 12 | Screening, Week 12 | Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 12 were reported. |
| Change From Screening in Serum Parathyroid Hormone Levels at Week 20 | Screening, Week 20 | Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 20 were reported. |
| Change From Screening in Serum Parathyroid Hormone Levels at Week 26 | Screening, Week 26 | Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 26 were reported. |
| Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up) | Screening, Week 30 (Follow-up) | Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 30 were reported. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to Week 30 | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have 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. A TEAE is defined as an AE with an onset date on or after the first application of the study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit | Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up) | Percent BSA was calculated by modified rules of nines (pediatric participants). Estimate were made from the following for a child up to the age of one year: head and neck total for front and back - 18%; thorax and abdomen-front -18%; thorax and abdomen-back - 18%; each upper limb total for front and back - 9%; each lower limb total for front and back - 14%. For over the age of one year, the relative percentage of BSA changes as follows: the head decreases by 1% per year and the lower limbs increase by 0.5% per year. By the age of ten years, the relative proportions assume the values for adult BSA as follows: perineum becomes 1%; each lower limb becomes a total of 18% front and back; head and neck become 9% total for front and back. |
| Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit | Weeks 4, 8, 12, 20, 26 and 30 (Follow-up) | The IGA is a 0 to 4 point scale. Where, 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). |
| Change From Baseline in Pruritus Score at Each Visit | Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up) | Pruritus was scored on a 0 to 4 point scale. Where, 0 = none (no-itching); 1 = mild (slight itching, not really bothersome); 2 = moderate (definite itching that is somewhat bothersome without loss of sleep); 3 = severe (intense itching that has caused pronounced discomfort, night rest interrupted); 4 = very severe (very severe itching that has caused pronounced discomfort during the night and daily activities). Positive change from baseline indicate worsening of indication. |
Countries
Belgium, Canada, Germany, Italy, United States
Participant flow
Pre-assignment details
A total of 88 participants were screened. Only 54 participants out of 88 were enrolled and received study drug, of which 41 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Calcitriol 3 mcg/g Participants received calcitriol 3 mcg/g ointment applied twice daily without exceeding a maximum of 0.5 g/kg of body weight or 28 g daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks. | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Calcitriol 3 mcg/g |
|---|---|
| Age, Categorical <=18 years | 54 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 10.3 Years STANDARD_DEVIATION 3.99 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 46 Participants |
| Region of Enrollment Belgium | 2 Participants |
| Region of Enrollment Canada | 11 Participants |
| Region of Enrollment Germany | 4 Participants |
| Region of Enrollment Italy | 5 Participants |
| Region of Enrollment United States | 32 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 54 |
| other Total, other adverse events | 9 / 54 |
| serious Total, serious adverse events | 0 / 54 |
Outcome results
Primary
Change From Screening in Serum Albumin Levels at Week 12
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 12 were reported.
Time frame: Screening, Week 12
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Serum Albumin Levels at Week 12 | -0.8 g/L | Standard Deviation 2.03 |
Primary
Change From Screening in Serum Albumin Levels at Week 20
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 20 were reported.
Time frame: Screening, Week 20
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Serum Albumin Levels at Week 20 | -1.1 g/L | Standard Deviation 2.1 |
Primary
Change From Screening in Serum Albumin Levels at Week 26
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 26 were reported.
Time frame: Screening, Week 26
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Serum Albumin Levels at Week 26 | -0.8 g/L | Standard Deviation 2.09 |
Primary
Change From Screening in Serum Albumin Levels at Week 30 (Follow-up)
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 30 were reported.
Time frame: Screening, Week 30 (Follow-up)
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Serum Albumin Levels at Week 30 (Follow-up) | -0.2 g/L | Standard Deviation 2.95 |
Primary
Change From Screening in Serum Albumin Levels at Week 4
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported.
Time frame: Screening, Week 4
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Serum Albumin Levels at Week 4 | -1.0 gram per liter (g/L) | Standard Deviation 2.28 |
Primary
Change From Screening in Serum Albumin Levels at Week 8
Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 8 were reported.
Time frame: Screening, Week 8
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Serum Albumin Levels at Week 8 | -1.0 g/L | Standard Deviation 2.09 |
Primary
Change From Screening in Serum Parathyroid Hormone Levels at Week 12
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 12 were reported.
Time frame: Screening, Week 12
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Serum Parathyroid Hormone Levels at Week 12 | 0.04 pmol/L | Standard Deviation 1.4 |
Primary
Change From Screening in Serum Parathyroid Hormone Levels at Week 20
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 20 were reported.
Time frame: Screening, Week 20
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Serum Parathyroid Hormone Levels at Week 20 | 0.17 pmol/L | Standard Deviation 1.152 |
Primary
Change From Screening in Serum Parathyroid Hormone Levels at Week 26
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 26 were reported.
Time frame: Screening, Week 26
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Serum Parathyroid Hormone Levels at Week 26 | -0.07 pmol/L | Standard Deviation 1.744 |
Primary
Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up)
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 30 were reported.
Time frame: Screening, Week 30 (Follow-up)
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up) | 0.37 pmol/L | Standard Deviation 1.796 |
Primary
Change From Screening in Serum Parathyroid Hormone Levels at Week 8
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 8 were reported.
Time frame: Screening, Week 8
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Serum Parathyroid Hormone Levels at Week 8 | 0.09 pmol/L | Standard Deviation 1.451 |
Primary
Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4
Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 4 were reported.
Time frame: Screening, Week 4
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4 | 0.14 Picomole per liter (pmol/L) | Standard Deviation 0.967 |
Primary
Change From Screening in Serum Phosphate Levels at Week 12
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 12 were reported.
Time frame: Screening, Week 12
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Serum Phosphate Levels at Week 12 | 0.0237 mmol/L | Standard Deviation 0.17996 |
Primary
Change From Screening in Serum Phosphate Levels at Week 20
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 20 were reported.
Time frame: Screening, Week 20
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Serum Phosphate Levels at Week 20 | 0.0079 mmol/L | Standard Deviation 0.19925 |
Primary
Change From Screening in Serum Phosphate Levels at Week 26
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 26 were reported.
Time frame: Screening, Week 26
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Serum Phosphate Levels at Week 26 | 0.0091 mmol/L | Standard Deviation 0.21262 |
Primary
Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up)
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 30 were reported.
Time frame: Screening, Week 30 (Follow-up)
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up) | 0.0145 mmol/L | Standard Deviation 0.18727 |
Primary
Change From Screening in Serum Phosphate Levels at Week 4
Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 4 were reported.
Time frame: Screening, Week 4
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Serum Phosphate Levels at Week 4 | 0.0334 mmol/L | Standard Deviation 0.17093 |
Primary
Change From Screening in Urine Calcium/Creatinine Ratio at Week 12
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 12 were reported.
Time frame: Screening, Week 12
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Urine Calcium/Creatinine Ratio at Week 12 | -0.0164 Ratio | Standard Deviation 0.1434 |
Primary
Change From Screening in Urine Calcium/Creatinine Ratio at Week 26
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 26 were reported.
Time frame: Screening, Week 26
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Urine Calcium/Creatinine Ratio at Week 26 | 0.0456 Ratio | Standard Deviation 0.15588 |
Primary
Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up)
Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 30 were reported.
Time frame: Screening, Week 30 (Follow-up)
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up) | 0.0715 Ratio | Standard Deviation 0.14333 |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have 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. A TEAE is defined as an AE with an onset date on or after the first application of the study drug.
Time frame: Up to Week 30
Population: Safety population included as all the participants who have applied the study drug at least once.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Calcitriol 3 mcg/g | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 20 Participants |
Secondary
Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit
Percent BSA was calculated by modified rules of nines (pediatric participants). Estimate were made from the following for a child up to the age of one year: head and neck total for front and back - 18%; thorax and abdomen-front -18%; thorax and abdomen-back - 18%; each upper limb total for front and back - 9%; each lower limb total for front and back - 14%. For over the age of one year, the relative percentage of BSA changes as follows: the head decreases by 1% per year and the lower limbs increase by 0.5% per year. By the age of ten years, the relative proportions assume the values for adult BSA as follows: perineum becomes 1%; each lower limb becomes a total of 18% front and back; head and neck become 9% total for front and back.
Time frame: Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable this outcome measure and 'n' (number of participants analyzed) signifies number of participants evaluable for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit | Week 4 | -1.3 Percent BSA | Standard Deviation 2.85 |
| Calcitriol 3 mcg/g | Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit | Week 8 | -2.5 Percent BSA | Standard Deviation 4.03 |
| Calcitriol 3 mcg/g | Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit | Week 12 | -3.4 Percent BSA | Standard Deviation 4.11 |
| Calcitriol 3 mcg/g | Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit | Week 20 | -4.4 Percent BSA | Standard Deviation 4.61 |
| Calcitriol 3 mcg/g | Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit | Week 26 | -3.9 Percent BSA | Standard Deviation 4.52 |
| Calcitriol 3 mcg/g | Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit | Week 30 | -4.7 Percent BSA | Standard Deviation 5.91 |
Secondary
Change From Baseline in Pruritus Score at Each Visit
Pruritus was scored on a 0 to 4 point scale. Where, 0 = none (no-itching); 1 = mild (slight itching, not really bothersome); 2 = moderate (definite itching that is somewhat bothersome without loss of sleep); 3 = severe (intense itching that has caused pronounced discomfort, night rest interrupted); 4 = very severe (very severe itching that has caused pronounced discomfort during the night and daily activities). Positive change from baseline indicate worsening of indication.
Time frame: Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable this outcome measure and 'n' (number of participants analyzed) signifies number of participants evaluable for each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcitriol 3 mcg/g | Change From Baseline in Pruritus Score at Each Visit | Week 4 | -0.6 Units on a scale | Standard Deviation 0.85 |
| Calcitriol 3 mcg/g | Change From Baseline in Pruritus Score at Each Visit | Week 8 | -0.7 Units on a scale | Standard Deviation 0.64 |
| Calcitriol 3 mcg/g | Change From Baseline in Pruritus Score at Each Visit | Week 12 | -0.7 Units on a scale | Standard Deviation 0.88 |
| Calcitriol 3 mcg/g | Change From Baseline in Pruritus Score at Each Visit | Week 20 | -0.7 Units on a scale | Standard Deviation 0.96 |
| Calcitriol 3 mcg/g | Change From Baseline in Pruritus Score at Each Visit | Week 26 | -0.9 Units on a scale | Standard Deviation 0.98 |
| Calcitriol 3 mcg/g | Change From Baseline in Pruritus Score at Each Visit | Week 30 | -0.8 Units on a scale | Standard Deviation 1.05 |
Secondary
Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit
The IGA is a 0 to 4 point scale. Where, 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: Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)
Population: Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable this outcome measure and 'n' (number of participants analyzed) signifies number of participants evaluable for each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Calcitriol 3 mcg/g | Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit | Week 4 | 3 Participants |
| Calcitriol 3 mcg/g | Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit | Week 8 | 5 Participants |
| Calcitriol 3 mcg/g | Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit | Week 12 | 15 Participants |
| Calcitriol 3 mcg/g | Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit | Week 20 | 14 Participants |
| Calcitriol 3 mcg/g | Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit | Week 26 | 19 Participants |
| Calcitriol 3 mcg/g | Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit | Week 30 | 17 Participants |