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Trial record 14 of 154 for:    Dermatitis, Atopic, 8

A Study to Evaluate the Effectiveness and Safety of a Topical Ointment to Treat Subjects With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT02068352
Recruitment Status : Completed
First Posted : February 21, 2014
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
The purpose of this study is to investigate the effectiveness and safety of 2 concentrations of OPA-15406 compared to vehicle in subjects with atopic dermatitis.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: OPA-15406 Drug: Placebo Phase 2

Detailed Description:
Atopic dermatitis is a disease mainly characterized by pruritic eczema, and patients with the disease experience repeated exacerbations and remissions. . Therapeutic guidelines for the disease, currently being developed in many countries, all recognize AD as chronic eczema that is accompanied by the physiological dysfunction of the skin and in which inflammation is caused by various nonspecific stimuli or specific allergens. OPA 15406 is a type-4 phosphodiesterase (PDE4) inhibitor. PDE4 inhibitors are thought to be useful for allergic inflammatory diseases. This is a Phase 2 dose ranging study to evaluate the efficacy of two concentrations of OPA 15406 ointment compared to vehicle, when administered topically twice daily in subjects with mild to moderate AD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Multi-center, Randomized, Double-blind, Vehicle-controlled, Three-arm, Parallel Group Study to Assess the Safety, Tolerability, and Efficacy of Topical OPA-15406 Ointment, in Subjects With Mild/Moderate Atopic Dermatitis
Study Start Date : June 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: 0.3% OPA-15406
BID 0.3% OPA-15406 Ointment, N = 40
Drug: OPA-15406
0.3% or 1% OPA-15406 topical ointment, applied twice daily for 8 weeks

Experimental: 1% OPA-15406
BID 1% OPA-15406 Ointment, N = 40
Drug: OPA-15406
0.3% or 1% OPA-15406 topical ointment, applied twice daily for 8 weeks

Placebo Comparator: Placebo
BID 0% Vehicle Ointment, N = 40
Drug: Placebo



Primary Outcome Measures :
  1. Safety as assessed by incidence and severity of adverse events. [ Time Frame: 8 weeks ]
  2. Incidence of success (as defined by a score of 0 (clear) or 1 (almost clear) with at least a 2 grade reduction from Baseline) in the overall IGA score at Week 4 for OPA 15406 concentrations vs. vehicle. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Incidence of success in the overall IGA score at Week 8 for OPA 15406 concentrations vs. vehicle. [ Time Frame: 56 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects 10-70 years of age
  • Diagnosis of atopic dermatitis (AD)
  • History of AD for at least 3 years
  • AD affecting greater than or equal to 5% and less than or equal to 40% of total Body Surface Area (BSA) at Baseline
  • Investigator's Global Assessment of Disease Severity score of 2 (mild) or 3 (moderate) in the selected treatment area(s)

Exclusion Criteria:

  • Contact or atopic dermatitis flare within 28 days of the Baseline (Day 1) visit.
  • Concurrent diseases/conditions and history of other diseases/conditions in the selected treatment areas(s) that may have an impact on the study assessments.

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): NCT02068352


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Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT02068352     History of Changes
Other Study ID Numbers: 271-12-205
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: January 2016
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Atopic Dermatitis, Eczema
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases