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Completed

NCT Number: NCT00419666

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

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.

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Key information

Conditions

Chronic Plaque Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Newlab Clinical Research, Inc., St. John's, Newfoundland and Labrador, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of chronic plaque psoriasis
  • 10 - 35% BSA of involved skin
  • Age 12 - 17

Exclusion criteria

  • Other type of psoriasis (other than plaque)
  • Significant abnormal lab findings
  • Vit D insufficiency

Treatment and study plan

Calcitriol 3mcg/g

Drug

Calcitriol 3mcg/g ointment applied twice daily for 56 weeks.

Other names: CD2027, Vectical

Primary outcomes

  1. Trough Plasma Levels (Ctrough) of Calcitriol

    Time frame: Day 0 (Baseline), Day 14, Day 21, and Day 56

    Trough plasma levels (Ctrough) of calcitriol was reported.

  2. The Observed Peak Drug Concentration (Cmax) of Calcitriol

    Time frame: Day 0 (Baseline), Day 21

    Cmax of calcitriol was reported.

  3. Area Under the Concentration-Time Curve From Pre-Application (T0) Through 9 Hours Post Dosing (AUC [0-9 Hours])

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

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

  4. Area Under the Concentration-Time Curve From Pre-Application (T0) Through 12 Hours Post Dosing (AUC [0-12 Hours])

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

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

  5. Time at Which Maximum Concentration (Cmax) Occurred (Tmax)

    Time frame: Day 0 (Baseline), Day 21

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

Secondary outcomes

  1. Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium, Urinary (U) Calcium Random) and Phosphorus Homeostasis up to Day 56

    Time frame: From baseline (Day 0) 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.

  2. Change From Baseline in Effect of Calcitriol Ointment on Calcium (Serum Calcium Albumin Adjusted) Homeostasis up to Day 56

    Time frame: From baseline (Day 0) 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.

  3. Change From Baseline in Effect of Calcitriol Ointment on Calcium (Urinary Calcium/Creatinine Ratio) Homeostasis up to Day 56

    Time frame: From baseline (Day 0) 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.

  4. Number of Participants With Adverse Events

    Time frame: From start of the study to Day 56

    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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

PK and PD of Calcitriol Following Twice Daily Application of Calcitriol 3 µg/g Ointment Under Conditions of Maximal Use in Adolescents With Plaque Psoriasis

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 9, 2007
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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