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

NCT ID: NCT01782729

Last Updated: 2013-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-11-30

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 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 pediatric participants.

Detailed Description

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, 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.

Conditions

Dermatitis, Atopic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tacrolimus ointment (pediatric)

Tacrolimus ointment, 0.03 percent twice a day for pediatric population for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first.

Group Type: EXPERIMENTAL

Tacrolimus

Intervention Type: DRUG

Tacrolimus ointment, 0.03 percent twice a day for pediatric population for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first.

Interventions

Tacrolimus

Tacrolimus ointment, 0.03 percent twice a day for pediatric population for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag Ltd.,Thailand

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag Ltd.,Thailand Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Ltd.,Thailand

Locations

Hanoi, , Vietnam

Countries

Vietnam

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=2485&filename=CR017827_CSR.pdf

The efficacy and safety of tacrolimus ointment in pediatric patients with moderate to severe atopic dermatitis

Other Identifiers

R098924ADM4007

Identifier Type: -

Identifier Source: secondary_id

CR017827

Identifier Type: -

Identifier Source: org_study_id