NCT02605057

Brief Summary

Given that LEO 80185 gel takes effect in the upper layer of the skin, it is important to compare and examine the amount of the drug in the upper layer of the skin with that of Dovobet® Ointment. Therefore, a dermatopharmacokinetic study will be conducted in healty adult male volunteers to evaluate pharmacokinetics of LEO 80185 gel and Dovobet® Ointment in the stratum corneum. In this trial, a single application of LEO 80185 gel and Dovobet® ointment will be applied to multiple test sites on the back of healthy Japanese male adults and the trial is designed to compare the amount of each of the active ingredients at steady state or close-to-steady state between LEO 80185 gel and Dovobet® Ointment. The amount of calcipotriol and betamethasone dipropionate in the stratum corneum will be assessed by use of tape stripping.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

February 24, 2025

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

November 12, 2015

Last Update Submit

February 21, 2025

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (2)

  • The amount of calcipotriol in the stratum corneum

    Concentrations will be used to determine steady state

    24 hours

  • The amount of betamethasone dipropionate in the stratum corneum

    Concentrations will be used to determine steady state

    24 hours

Secondary Outcomes (1)

  • Safety (Number and type of adverse events)

    24 hours

Study Arms (2)

LEO 80185 gel

EXPERIMENTAL

LEO 80185 gel will be allocated to 7 different test sites on each subject

Drug: LEO 80185 gel

Dovobet Ointment

EXPERIMENTAL

Dovobet Ointment will be allocated to 7 different test sites on each subject

Drug: Dovobet(r) Ointment

Interventions

LEO 80185 gelDRUG
LEO 80185 gel
Dovobet(r) OintmentDRUG
Dovobet Ointment

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed and dated informed consent form has been obtained.
  • Healthy Japanese male subjects according to medical history, physical examination, ECG, vital signs and laboratory tests.
  • Aged 20 to 40 years inclusive.
  • Subjects with enough skin area for application of the investigational products.

You may not qualify if:

  • Body Mass Index outside the range 18-25 kg/m²
  • History or presence of alcohol or drug abuse.
  • History of allergic reaction to any medications.
  • Subjects with, or with a history of, systemic or cutaneous disease that could in any way confound interpretation of the trial results (e.g. atopic dermatitis, eczema, psoriasis)
  • Known or suspected hypersensitivity to any component of LEO 80185 gel or Dovobet® ointment.
  • Known or suspected hepatic, renal or cardiac disorders.
  • Known or suspected disorders of calcium metabolism associated with hypercalcaemia or albumin-corrected serum calcium above the reference range from the sample taken during screening.
  • Subjects with any of the following skin diseases/skin abnormalities that impede the assessment of the application site (back):
  • eczema/dermatitis or abnormal pigmentation
  • bruises or scars
  • inflammation due to sunburn
  • history and/or presence of skin allergy such as atopic dermatitis
  • history of drug hypersensitivity
  • Signs of skin irritation/disease/disorders/symptoms or blemishes at the planned site of application (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn)
  • Subjects suspected of infection based on the infection testing results from the sample taken during screening (Hepatitis B surface antigen, HCV antibiody, HIV antigen/antibody, serological test for syphilis).
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shinanokai Shinanozaka Clinic

Tokyo, 160-0017, Japan

Location

Related Links

MeSH Terms

Interventions

Ointments

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Masahiko Takeshi, MD

    Shinanokai Shinanozaka Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2015

First Posted

November 16, 2015

Study Start

November 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

February 24, 2025

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)