- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01828879
An Efficacy and Safety Study of Tacrolimus Ointment in Adult Participants With Atopic Dermatitis
April 8, 2013 updated by: Janssen-Cilag Ltd.,Thailand
The Efficacy and Safety of Tacrolimus Ointment in Adult Patients With Moderate to Severe Atopic Dermatitis
The purpose of this study is to evaluate the safety and efficacy of tacrolimus ointment in treating the signs and symptoms of moderate (medium level of seriousness) to severe (very serious, life threatening) atopic dermatitis (an intensely pruritic [itching], chronic [lasting a long time], inflammatory [pain and swelling], immunologically based skin disease with a genetic predisposition [latent susceptibility to disease at the genetic level]) in adult participants.
Study Overview
Detailed Description
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), randomized (like the flip of a coin), multi-center study in adult participants with moderate to severe atopic dermatitis.
Participants will be treated with 0.1 percent concentration of tacrolimus ointment which will be applied twice daily for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first.
The study will consist of 6 visits: pre-study (optional), Baseline or Day 1, Weeks 1, 2, 3 and 4 (end-of-treatment).
The ointment should be applied at least 2 hours before or at least 30 minutes after bathing, showering, shaving, use of sauna, or heavy exercise (i.e.
causes sweating).
On study visit days, the ointment should be applied at least 2 hours before the visit.
Efficacy evaluation will be done at all subsequent study visits in participants receiving study drug for at least 3 consecutive days (minimum of 5 applications) while the participants who will receive at least 1 application of the study drug, will be evaluated for safety.
Primary efficacy evaluation will be based on the Physician's Global Evaluation of Clinical Response (PhGECR).
Participants' safety will be monitored throughout the study.
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hanoi, Vietnam
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Hochiminh, Vietnam
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants with a diagnosis of atopic dermatitis using Hanifin and Rajka Criteria (major criteria: pruritus, lichenification [crusting over], chronic relapsing [the return of a medical problem] course, family history of atopy and minor criteria: xerosis [dry skin], ichthyosis [skin disorders characterized by dryness, roughness, and scaliness], immediate Type I reactions [reactions which occur within minutes of exposure to challenging antigen: substances that are recognized by the immune system and induce an immune reaction] to skin test antigens) involving at least 10 percent of the body surface area
- Participants not having other skin disorders and severe heart, liver, kidney and lung diseases
- Participants who have given informed consent
- Female participants with child-bearing potential must have a negative pregnancy test
- Participant meets the following washout requirements (washout period ranging from 1-42 days) before study: 1 day (for non-medicated topical [applied to skin; surface] agents); 7 days (for terfenadine, other non-sedating systemic antihistamines [drug used to treat allergic reaction], topical corticosteroids (steroid hormone), H1 and H2 antihistamines, antimicrobial [drug that kills bacteria and other germs], other medicated topical agents); 14 days (for intranasal [delivery of medications through the nasal mucosa] and/or inhaled corticosteroids); 28 days (for light treatments [ultra violet rays A, ultra violet rays B], non-steroidal immunosuppressants [drug which suppresses the body's immune response, used in transplantation and diseases caused by disordered immunity], other investigational drugs and systemic corticosteroids); and 42 days (for astemizole)
Exclusion Criteria:
- Participant with a skin disorder other than atopic dermatitis in the areas to be treated
- Participant who have pigmentation or extensive scarring or pigmented lesions (abnormal area of tissue, such as a wound, sore, rash, or boil) in the areas to be treated which would interfere with rating of efficacy parameters
- Participant who have clinically infected atopic dermatitis at baseline
- Participant with a systemic disease, including cancer (abnormal tissue that grows and spreads in the body until it kills) or a history of cancer or Human Immunodeficiency Virus (HIV: a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person), which would contraindicate (medical reasons that prevent a person from using a certain drug or treatment) the use of immunosuppressants
- Participant with a known hypersensitivity (altered reactivity to an antigen) to macrolides (drugs exhibiting antibiotic properties) or any excipient of the ointment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tacrolimus ointment
Tacrolimus ointment, 0.1 percent will be applied twice daily, in adult population for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first.
|
Tacrolimus ointment, 0.1 percent will be applied twice daily, in adult population for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physician's Global Evaluation of Clinical Response (PhGECR)
Time Frame: Week 4
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PhGECR scale evaluates the change in the lesions of atopic dermatitis, which is defined as the lesions identified by Investigator for treatment at Baseline only, using scores ranging from, less than 0 to 100: wherein, less than 0=worse, 0-29=no appreciable improvement, 30-49=slight improvement, 50-74=moderate improvement, 75-89=marked improvement, 90-99=excellent improvement and 100=cleared.
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Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eczema Area and Severity Index (EASI)
Time Frame: Week 1, 2, 3 and 4
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A composite index of area involved and severity of the signs of atopic dermatitis in the 4 regions (head and neck, upper limbs, trunk, lower limbs) will be calculated using the physician's assessment of individual signs using a scale ranging from 0 to 3: 0=absent, 1=mild, 2=moderate, 3=severe; and the affected area assessment (the percentage of body surface area affected by atopic dermatitis) of the lesions defined in the baseline treatment area will be estimated by the physician on the basis of area score ranging from 0 to 6: 0=0 percent and 6=90 to 100 percent.
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Week 1, 2, 3 and 4
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Participant's Assessment of Treatment Effects
Time Frame: Week 1, 2, 3 and 4
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Participants will make 2 assessments at each study visit (before and after treatment) based on all affected areas (ratio of 100 percent).
The assessment rates include: much better, better, slightly better, same, slightly worse, worse.
Much better and better is considered good.
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Week 1, 2, 3 and 4
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Participant's Assessment of Itch
Time Frame: Week 1, 2, 3 and 4
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Participant's itch will be assessed using a Visual Analog Scale ranging from 0 to 100: 0-19=no or slight itch; 20-39=mild itch; 40-59=moderate itch; 60-79=severe itch; 80-100=worst itch.
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Week 1, 2, 3 and 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
March 21, 2013
First Submitted That Met QC Criteria
April 8, 2013
First Posted (Estimate)
April 11, 2013
Study Record Updates
Last Update Posted (Estimate)
April 11, 2013
Last Update Submitted That Met QC Criteria
April 8, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Skin Diseases, Genetic
- Hypersensitivity
- Skin Diseases, Eczematous
- Dermatitis
- Dermatitis, Atopic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Immunosuppressive Agents
- Immunologic Factors
- Calcineurin Inhibitors
- Tacrolimus
Other Study ID Numbers
- CR017833
- R098924ADM4006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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