Status:
COMPLETED
An Efficacy and Safety Study of Tacrolimus Ointment in Adult Participants With Atopic Dermatitis
Lead Sponsor:
Janssen-Cilag Ltd.,Thailand
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 threa...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01828879
Start Date
November 1 2007
End Date
December 1 2009
Last Update
April 11 2013
Active Locations (2)
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1
Hanoi, Vietnam
2
Hochiminh, Vietnam