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Trial record 72 of 272 for:    Betamethasone

Skin Irritation of LEO 90100 Foam (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects

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ClinicalTrials.gov Identifier: NCT03442244
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
This trial is looking at whether the LEO 90100 foam causes irritation of the skin in healthy Japanese male adults without psoriasis. A single application of LEO 90100 foam and its vehicle will each be made to 2 body sites in 20 subjects.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: LEO 90100 foam Drug: Vehicle of LEO 90100 foam Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Skin Irritation Trial of LEO 90100 Foam (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : February 20, 2018
Actual Study Completion Date : February 20, 2018


Arm Intervention/treatment
Experimental: LEO 90100 foam
Each subject has each of the 2 investigational products applied at the same time on 2 sites on the back. The location on which the treatments are applied is randomised in a double-blinded manner LEO 90100 foam contains Calcipotriol hydrate 52.2 μg/g (equivalent to 50.0 μg/g calcipotriol) plus Betamethasone dipropionate 0.643 mg/g
Drug: LEO 90100 foam
Each subject has each of the 2 treatments applied at the same time on 2 different sites on the back

Placebo Comparator: Vehicle foam

Each subject has each of the 2 investigational products applied at the same time on 2 sites on the back. The location on which the treatments are applied is randomised in a double-blinded manner.

Foam vehicle does not contain active ingredients

Drug: Vehicle of LEO 90100 foam
Each subject has each of the 2 treatments applied at the same time on 2 different sites on the back




Primary Outcome Measures :
  1. Skin irritation [ Time Frame: Up to Day 4 ]
    Skin irritation measured as skin irritation index (summation of clinical scores [ranging from no reaction to blisters] from 49 hrs to 72 hrs after aplication) divided by total number of skin irritation assessments

  2. Photo irritation [ Time Frame: Up to Day 4 ]
    Positive ratios calculated from the photo irritation scores



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

Key Inclusion Criteria:

  • Signed informed consent has been obtained.
  • Healthy Japanese male subjects.
  • Aged 20 to 40 years inclusive.

Key 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): NCT03442244


Locations
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Japan
Medical Co. LTA HAKATA clinic
Fukuoka, Japan
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: NCT03442244     History of Changes
Other Study ID Numbers: LP0053-1007
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents