An Efficacy and Safety Study of Tacrolimus Ointment in Pediatric Participants With Atopic Dermatitis

Launched by JANSSEN-CILAG LTD.,THAILAND · Feb 1, 2013

Keywords

ClinConnect Summary

This is an open-label (all people know the identity of the intervention) study in pediatric (2-12 years) participants with moderate to severe atopic dermatitis. Participants will be treated with 0.03 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 visits will consist of 6 visits: pre-study (optional), Baseline, Weeks 1, 2, 3 and 4. The ointment should be applied at least 2 hours before or at least 30 minutes after bathing...

Gender

ALL

Eligibility criteria

• • 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
• • Participant or parent/guardian of pediatric participants has given informed consent
• • Participants meets the following washout requirements (washout period ranging from 1 to 42 days) before the 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, 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)
• • Participant and, if applicable, parent/guardian, agrees to comply with study requirements and is able to be at the clinic for all required study visits Exclusion Criteria: - Participants with a skin disorder other than atopic dermatitis in the treatment area
• • Participant has 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 has clinically infected atopic dermatitis at baseline
• • Participants with a known hypersensitivity (altered reactivity to an antigen) to macrolides (drugs exhibiting antibiotic properties) or any excipient of the ointment
• • Participant has 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