Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous areas) for 56 days (8 weeks). Full Pharmacokinetic (PK) and Pharmacodynamic (PD) profile will be collected during the first 3 weeks of the study; safety and efficacy data will be collected for the 8 weeks of the treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcitriol 3mcg/g | Experimental | Participants receive calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcitriol 3mcg/g | Drug | Calcitriol 3mcg/g ointment applied twice daily for 56 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough Plasma Levels (Ctrough) of Calcitriol | Trough plasma levels (Ctrough) of calcitriol was reported. | Day 0 (Baseline), Day 14, Day 21, and Day 56 |
| The Observed Peak Drug Concentration (Cmax) of Calcitriol | Cmax of calcitriol was reported. | Day 0 (Baseline), Day 21 |
| Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours]) | The AUC(0-9 hours) that is area under the plasma concentration-time curve from time 0 to 9 hours after dosing was reported. | 0 (predose) and 9 hours post dose on Day 0 (Baseline), Day 21 |
| Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours]) | The AUC(0-12 hours) that is area under the plasma concentration-time curve from time 0 to 12 hours after dosing was reported. | 0 (predose) and 12 hours post dose on Day 0 (Baseline), Day 21 |
| Time at Which Maximum Concentration (Cmax) Occurred (Tmax) | Tmax is the time to reach maximum concentration and was reported for calcitriol. | Day 0 (Baseline), Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56 | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Graeber, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Research of Arkansas | Little Rock | Arkansas | 72205 | United States | ||
| Children's Hospital, Department of Pediatric and Adolescent Dermatology |
A total of 25 participants were enrolled and completed the study.
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).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Calcitriol 3mcg/g | Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-to-Treat (ITT) population consisted of all participants who were enrolled and to whom medication was dispensed.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Calcitriol 3mcg/g | Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Trough Plasma Levels (Ctrough) of Calcitriol | Trough plasma levels (Ctrough) of calcitriol was reported. | Safety population consisted of all participants in the ITT population who had applied the study medication at least once. | Posted | Mean | Standard Deviation | Picograms Per Millilitre (pg/mL) | Day 0 (Baseline), Day 14, Day 21, and Day 56 |
|
|
From start of the study to Day 56
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcitriol 3mcg/g | Participants received calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | +1 | Clinical.Studies@galderma.com |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From baseline (Day 0) up to Day 56 |
| Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis up to Day 56 | 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. | From baseline (Day 0) up to Day 56 |
| Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis up to Day 56 | 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. | From baseline (Day 0) up to Day 56 |
| Number of Participants With Adverse Events | 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. | From start of the study to Day 56 |
| San Diego |
| California |
| 92123 |
| United States |
| Dermatology Center For Children & Young Adults | Eagan | Minnesota | 55121 | United States |
| University of Texas-Houston Medical Center Dept of Dermatology | Houston | Texas | 77030 | United States |
| Center for Clinical Studies | Webster | Texas | 77598 | United States |
| Nexus Clinical Research | St. John's | Newfoundland and Labrador | A1B 3E1 | Canada |
| Newlab Clinical Research, Inc. | St. John's | Newfoundland and Labrador | A1C 2H5 | Canada |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Primary | The Observed Peak Drug Concentration (Cmax) of Calcitriol | Cmax of calcitriol was reported. | Safety population consisted of all participants in the ITT population who had applied the study medication at least once. | Posted | Mean | Standard Deviation | pg/mL | Day 0 (Baseline), Day 21 |
|
|
|
| Primary | Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours]) | The AUC(0-9 hours) that is area under the plasma concentration-time curve from time 0 to 9 hours after dosing was reported. | Safety population consisted of all participants in the ITT population who had applied the study medication at least once. | Posted | Mean | Standard Deviation | Picograms. hours per millilitre(pg.h/mL) | 0 (predose) and 9 hours post dose on Day 0 (Baseline), Day 21 |
|
|
|
| Primary | Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours]) | The AUC(0-12 hours) that is area under the plasma concentration-time curve from time 0 to 12 hours after dosing was reported. | Safety population consisted all participants in the ITT population who had applied the study medication at least once. | Posted | Mean | Standard Deviation | pg.h/mL | 0 (predose) and 12 hours post dose on Day 0 (Baseline), Day 21 |
|
|
|
| Primary | Time at Which Maximum Concentration (Cmax) Occurred (Tmax) | Tmax is the time to reach maximum concentration and was reported for calcitriol. | Safety population consisted of all participants in the ITT population who had applied the study medication at least once. | Posted | Median | Full Range | hours | Day 0 (Baseline), Day 21 |
|
|
|
| Secondary | Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56 | 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. | Safety population consisted of all participants in the ITT population who had applied the study medication at least once. | Posted | Mean | Standard Deviation | milligrams per deciliter (Mg/dL) | From baseline (Day 0) up to Day 56 |
|
|
|
| Secondary | Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis up to Day 56 | 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. | Safety population consisted all participants in the ITT population who had applied the study medication at least once. | Posted | Mean | Standard Deviation | Millimoles Per Litre (mmol/L) | From baseline (Day 0) up to Day 56 |
|
|
|
| Secondary | Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis up to Day 56 | 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. | Safety population consisted of all participants in the ITT population who had applied the study medication at least once. | Posted | Mean | Standard Deviation | Ratio | From baseline (Day 0) up to Day 56 |
|
|
|
| Secondary | Number of Participants With Adverse Events | 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. | Safety population consisted of all participants in the ITT population who had applied the study medication at least once. | Posted | Count of Participants | Participants | From start of the study to Day 56 |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 8 |
| 25 |
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
Not provided
| D002776 |
| Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| Title | Measurements |
|---|---|
|