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Dermatopharmacokinetic Trial of LEO 90100 Foam

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ClinicalTrials.gov Identifier: NCT03476746
Recruitment Status : Completed
First Posted : March 26, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
This is a phase 1, single centre trial in Japanese healthy male subjects comparing the amount of active ingredients of LEO 90100 foam and Dovobet® ointment in the stratum corneum.

Condition or disease Intervention/treatment Phase
Healthy Drug: LEO 90100 foam Drug: Dovobet® ointment Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: A single application of LEO 90100 foam and Dovobet® ointment will be applied to multiple test sites on the innerside of both arms of trial subjects. The trial consists of 2 parts. The first part, (pilot part) will evaluate the pharmacokinetic profile of LEO 90100 foam and Dovobet® ointment by measuring the amount of each of the active ingredients in the stratum corneum and determine conditions for the second part of the trial. The second part (pivotal part) will compare the amount of each of the active ingredients at steady state or close-to-steady state between LEO 90100 foam and Dovobet® ointment. The sample size and the number of application sites in the pivotal part will be determined based on the results of the pilot part.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Dermatopharmacokinetic Trial of LEO 90100 Foam
Actual Study Start Date : March 20, 2018
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Daivobet

Arm Intervention/treatment
Experimental: LEO 90100 foam

LEO 90100 foam (containing calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g).

Pilot part: 6 single applications of LEO 90100 foam on Day 1 (for 12 sites in total).

Pivotal part: To be decided based on the result of the pilot part

Drug: LEO 90100 foam
A foam formulation of the active comparator Dovobet® ointment

Active Comparator: Dovobet® ointment

Pilot part: 6 single applications of Dovobet® ointment on Day 1 (for 12 sites in total).

Pivotal part: To be decided based on the result of the pilot part

Drug: Dovobet® ointment
Ointment formulation containing same active ingredients as LEO 90100 foam




Primary Outcome Measures :
  1. The amount of each of the 2 active ingredients, calcipotriol and betamethasone dipropionate, in the stratum corneum obtained by means of tape stripping after application of LEO 90100 foam and Dovobet® ointment. [ Time Frame: 2, 4, 6, 8, 12 and 24 hr after drug application. ]
    Amount (nanogram) of calcipotriol and betamethasone dipropionate in the stratum corneum will be compared between the two formulations by selected time points using an ANOVA model with treatment/formulation as systematic effect.


Secondary Outcome Measures :
  1. Safety data - number of adverse events [ Time Frame: up to 15 Days after drug application ]
    Number of adverse events



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Japanese male subjects, aged 20 to 40 years inclusive

Exclusion Criteria:

  • Body Mass Index outside the range 18-25 kg/m²
  • Use of any medication (systemic or topical) within 2 weeks of Day 1.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476746


Locations
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Japan
Investigational site
Fukuoka, Japan, 812-0025
Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Study Director LEO Pharma

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03476746     History of Changes
Other Study ID Numbers: LP0053-1417
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No