Trial Outcomes & Findings for Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis (NCT NCT02125279)

NCT ID: NCT02125279

Last Updated: 2021-02-18

Results Overview

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 54 participants
• Primary outcome timeframe: Screening, Week 4
• Results posted on: 2021-02-18

Participant Flow

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.

Participant milestones

Measure	Calcitriol 3 mcg/g Participants received calcitriol 3 microgram per gram (mcg/g) ointment applied twice daily without exceeding a maximum of 0.5 gram per kilogram (g/kg) of body weight or 28 gram (g) daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Overall Study STARTED	54
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Measure	Calcitriol 3 mcg/g Participants received calcitriol 3 microgram per gram (mcg/g) ointment applied twice daily without exceeding a maximum of 0.5 gram per kilogram (g/kg) of body weight or 28 gram (g) daily (whichever was the lower) up to 26 weeks. Participants were further followed up for 4 weeks.
Overall Study Lack of Efficacy	2
Overall Study Withdrawal by Subject	6
Overall Study Protocol Violation	1
Overall Study Lost to Follow-up	4

Baseline Characteristics

Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis

Baseline characteristics by cohort

Measure	Calcitriol 3 mcg/g n=54 Participants 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.
Age, Categorical <=18 years	54 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	10.3 Years STANDARD_DEVIATION 3.99 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment Canada	11 Participants n=5 Participants
Region of Enrollment Belgium	2 Participants n=5 Participants
Region of Enrollment United States	32 Participants n=5 Participants
Region of Enrollment Italy	5 Participants n=5 Participants
Region of Enrollment Germany	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=48 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Serum Albumin Levels at Week 4	-1.0 gram per liter (g/L) Standard Deviation 2.28

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 8 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=30 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Serum Albumin Levels at Week 8	-1.0 g/L Standard Deviation 2.09

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 12 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=48 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Serum Albumin Levels at Week 12	-0.8 g/L Standard Deviation 2.03

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 20 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=28 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Serum Albumin Levels at Week 20	-1.1 g/L Standard Deviation 2.10

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 26 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=40 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Serum Albumin Levels at Week 26	-0.8 g/L Standard Deviation 2.09

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 30 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=16 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Serum Albumin Levels at Week 30 (Follow-up)	-0.2 g/L Standard Deviation 2.95

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 12 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=48 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Urine Calcium/Creatinine Ratio at Week 12	-0.0164 Ratio Standard Deviation 0.14340

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 26 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=38 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Urine Calcium/Creatinine Ratio at Week 26	0.0456 Ratio Standard Deviation 0.15588

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 30 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=12 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up)	0.0715 Ratio Standard Deviation 0.14333

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 4 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=48 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Serum Phosphate Levels at Week 4	0.0334 mmol/L Standard Deviation 0.17093

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 12 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=48 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Serum Phosphate Levels at Week 12	0.0237 mmol/L Standard Deviation 0.17996

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 20 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=28 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Serum Phosphate Levels at Week 20	0.0079 mmol/L Standard Deviation 0.19925

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 26 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=40 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Serum Phosphate Levels at Week 26	0.0091 mmol/L Standard Deviation 0.21262

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 30 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=16 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up)	0.0145 mmol/L Standard Deviation 0.18727

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 4 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=44 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4	0.14 Picomole per liter (pmol/L) Standard Deviation 0.967

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 8 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=31 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Serum Parathyroid Hormone Levels at Week 8	0.09 pmol/L Standard Deviation 1.451

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 12 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=48 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Serum Parathyroid Hormone Levels at Week 12	0.04 pmol/L Standard Deviation 1.400

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 20 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=28 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Serum Parathyroid Hormone Levels at Week 20	0.17 pmol/L Standard Deviation 1.152

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 26 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=40 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Serum Parathyroid Hormone Levels at Week 26	-0.07 pmol/L Standard Deviation 1.744

PRIMARY outcome

Timeframe: 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.

Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 30 were reported.

Outcome measures

Measure	Calcitriol 3 mcg/g n=18 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up)	0.37 pmol/L Standard Deviation 1.796

PRIMARY outcome

Timeframe: Up to Week 30

Population: Safety population included as all the participants who have applied the study drug at least once.

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.

Outcome measures

Measure	Calcitriol 3 mcg/g n=54 Participants Participants received calcitriol 3 mcg/g ointment 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	20 Participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Calcitriol 3 mcg/g n=51 Participants Participants received calcitriol 3 mcg/g ointment 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.
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
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
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
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
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
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

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Calcitriol 3 mcg/g n=51 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Baseline in Pruritus Score at Each Visit Week 4	-0.6 Units on a scale Standard Deviation 0.85
Change From Baseline in Pruritus Score at Each Visit Week 8	-0.7 Units on a scale Standard Deviation 0.64
Change From Baseline in Pruritus Score at Each Visit Week 12	-0.7 Units on a scale Standard Deviation 0.88
Change From Baseline in Pruritus Score at Each Visit Week 20	-0.7 Units on a scale Standard Deviation 0.96
Change From Baseline in Pruritus Score at Each Visit Week 26	-0.9 Units on a scale Standard Deviation 0.98
Change From Baseline in Pruritus Score at Each Visit Week 30	-0.8 Units on a scale Standard Deviation 1.05

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Calcitriol 3 mcg/g n=51 Participants Participants received calcitriol 3 mcg/g ointment 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.
Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit Week 4	-1.3 Percent BSA Standard Deviation 2.85
Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit Week 8	-2.5 Percent BSA Standard Deviation 4.03
Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit Week 12	-3.4 Percent BSA Standard Deviation 4.11
Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit Week 20	-4.4 Percent BSA Standard Deviation 4.61
Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit Week 26	-3.9 Percent BSA Standard Deviation 4.52
Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit Week 30	-4.7 Percent BSA Standard Deviation 5.91

Adverse Events

Calcitriol 3 mcg/g

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Calcitriol 3 mcg/g n=54 participants at risk Participants received calcitriol 3 mcg/g ointment 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.
Infections and infestations Nasopharyngitis	11.1% 6/54 • From start of treatment up to follow up (30 weeks)
Skin and subcutaneous tissue disorders Skin Burning Sensation	5.6% 3/54 • From start of treatment up to follow up (30 weeks)

Additional Information

Clinical Operations

Galderma

Phone: 817 961 5000

Email: Clinical.Studies@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place