Trial Outcomes & Findings for A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis (NCT NCT00419666)

Results Overview

Trough plasma levels (Ctrough) of calcitriol was reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Day 0 (Baseline), Day 14, Day 21, and Day 56

Results posted on

2021-02-18

Participant Flow

The study was conducted in 7 sites (5 in United States and 2 in Canada) between 01 Aug 2006 (first participant enrolled) to 24 Sep 2009 (last participant completed).

A total of 25 participants were enrolled and completed the study.

Participant milestones

Participant milestones
Measure	Calcitriol 3mcg/g Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Calcitriol 3mcg/g n=25 Participants Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
Age, Categorical <=18 years	25 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	14.7 Years STANDARD_DEVIATION 1.63 • n=93 Participants
Sex: Female, Male Female	14 Participants n=93 Participants
Sex: Female, Male Male	11 Participants n=93 Participants
Race/Ethnicity, Customized Race · Caucasian	16 Participants n=93 Participants
Race/Ethnicity, Customized Race · Black	2 Participants n=93 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=93 Participants
Race/Ethnicity, Customized Race · Hispanic	4 Participants n=93 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=93 Participants

PRIMARY outcome

Timeframe: Day 0 (Baseline), Day 14, Day 21, and Day 56

Population: Safety population consisted of all participants in the ITT population who had applied the study medication at least once.

Trough plasma levels (Ctrough) of calcitriol was reported.

Outcome measures

Outcome measures
Measure	Calcitriol 3mcg/g n=25 Participants Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
Trough Plasma Levels (Ctrough) of Calcitriol Day 21	61.87 Picograms Per Millilitre (pg/mL) Standard Deviation 17.703
Trough Plasma Levels (Ctrough) of Calcitriol Day 0 (Baseline)	65.04 Picograms Per Millilitre (pg/mL) Standard Deviation 18.851
Trough Plasma Levels (Ctrough) of Calcitriol Day 14	62.53 Picograms Per Millilitre (pg/mL) Standard Deviation 17.742
Trough Plasma Levels (Ctrough) of Calcitriol Day 56	61.46 Picograms Per Millilitre (pg/mL) Standard Deviation 22.811

PRIMARY outcome

Timeframe: Day 0 (Baseline), Day 21

Population: Safety population consisted of all participants in the ITT population who had applied the study medication at least once.

Cmax of calcitriol was reported.

Outcome measures

Outcome measures
Measure	Calcitriol 3mcg/g n=25 Participants Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
The Observed Peak Drug Concentration (Cmax) of Calcitriol Day 0 (Baseline)	75.74 pg/mL Standard Deviation 24.337
The Observed Peak Drug Concentration (Cmax) of Calcitriol Day 21	73.18 pg/mL Standard Deviation 21.514

PRIMARY outcome

Timeframe: 0 (predose) and 9 hours post dose on Day 0 (Baseline), Day 21

Population: Safety population consisted of all participants in the ITT population who had applied the study medication at least once.

The AUC(0-9 hours) that is area under the plasma concentration-time curve from time 0 to 9 hours after dosing was reported.

Outcome measures

Outcome measures
Measure	Calcitriol 3mcg/g n=25 Participants Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours]) Day 0 (Baseline)	575.12 Picograms. hours per millilitre(pg.h/mL) Standard Deviation 181.761
Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours]) Day 21	549.29 Picograms. hours per millilitre(pg.h/mL) Standard Deviation 155.277

PRIMARY outcome

Timeframe: 0 (predose) and 12 hours post dose on Day 0 (Baseline), Day 21

Population: Safety population consisted all participants in the ITT population who had applied the study medication at least once.

The AUC(0-12 hours) that is area under the plasma concentration-time curve from time 0 to 12 hours after dosing was reported.

Outcome measures

Outcome measures
Measure	Calcitriol 3mcg/g n=25 Participants Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours]) Day 0 (Baseline)	764.74 pg.h/mL Standard Deviation 230.003
Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours]) Day 21	737.74 pg.h/mL Standard Deviation 203.740

PRIMARY outcome

Timeframe: Day 0 (Baseline), Day 21

Population: Safety population consisted of all participants in the ITT population who had applied the study medication at least once.

Tmax is the time to reach maximum concentration and was reported for calcitriol.

Outcome measures

Outcome measures
Measure	Calcitriol 3mcg/g n=25 Participants Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
Time at Which Maximum Concentration (Cmax) Occurred (Tmax) Day 0 (Baseline)	4.00 hours Interval 0.0 to 9.0
Time at Which Maximum Concentration (Cmax) Occurred (Tmax) Day 21	3.97 hours Interval 0.0 to 9.0

SECONDARY outcome

Timeframe: From baseline (Day 0) up to Day 56

Population: Safety population consisted of all participants in the ITT population who had applied the study medication at least once.

Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Phosphorus homeostasis was analyzed with phosphorus as parameter. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium, U calcium random) and phosphorus homeostasis up to Day 56 was reported.

Outcome measures

Outcome measures
Measure	Calcitriol 3mcg/g n=25 Participants Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56 Phosphorus	0.20 milligrams per deciliter (Mg/dL) Standard Deviation 0.641
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56 Serum Calcium	0.08 milligrams per deciliter (Mg/dL) Standard Deviation 0.254
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56 Urinary (U) Calcium Random	1.00 milligrams per deciliter (Mg/dL) Standard Deviation 6.767

SECONDARY outcome

Timeframe: From baseline (Day 0) up to Day 56

Population: Safety population consisted all participants in the ITT population who had applied the study medication at least once.

Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (serum calcium albumin adjusted) homeostasis up to Day 56 was reported.

Outcome measures

Outcome measures
Measure	Calcitriol 3mcg/g n=25 Participants Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis up to Day 56	-0.01 Millimoles Per Litre (mmol/L) Standard Deviation 0.083

SECONDARY outcome

Timeframe: From baseline (Day 0) up to Day 56

Population: Safety population consisted of all participants in the ITT population who had applied the study medication at least once.

Calcium homeostasis was analyzed with serum calcium albumin adjusted, serum calcium, urinary calcium/creatinine ratio, urinary (U) calcium random as parameters. Change from baseline in the effect of calcitriol ointment on calcium (urinary calcium/creatinine ratio) homeostasis up to Day 56 was reported.

Outcome measures

Outcome measures
Measure	Calcitriol 3mcg/g n=25 Participants Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis up to Day 56	0.01 Ratio Standard Deviation 0.076

SECONDARY outcome

Timeframe: From start of the study to Day 56

Population: Safety population consisted of all participants in the ITT population who had applied the study medication at least once.

An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding assessed as clinically significant and different from the baseline visit), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of participants with adverse events were reported.

Outcome measures

Outcome measures
Measure	Calcitriol 3mcg/g n=25 Participants Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
Number of Participants With Adverse Events	13 Participants

Adverse Events

Calcitriol 3mcg/g

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Calcitriol 3mcg/g n=25 participants at risk Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days.
Skin and subcutaneous tissue disorders Psoriasis	8.0% 2/25 • From start of the study to Day 56
Infections and infestations Nasopharyngitis	8.0% 2/25 • From start of the study to Day 56
Injury, poisoning and procedural complications Excoriation	8.0% 2/25 • From start of the study to Day 56
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	8.0% 2/25 • From start of the study to Day 56

Additional Information

Clinical Operations

Galderma

Phone: 817 961 5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER