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

NCT01782729 | Completed Phase 4

• 2 other identifiers: CR017827R098924ADM4007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Atopic

Keywords

Dermatitis, Atopic; Tacrolimus

Outcome Measures

Primary Outcomes (1)

• Physician's Global Evaluation of Clinical Response (PhGECR) at Week 4

  The 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.

  Week 4

Secondary Outcomes (3)

• Eczema Area and Severity Index (EASI)

  Week 1, 2, 3 and 4

• Participant's Assessment of Treatment Effects

  Week 1, 2,3 and 4

• Participant's Assessment of Itch

  Week 1,2, 3 and 4

Study Arms (1)

Tacrolimus ointment (pediatric)

EXPERIMENTAL

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.

Drug: Tacrolimus

Interventions

Tacrolimus 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.

Tacrolimus ointment (pediatric)

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Ltd.,Thailand: lead

Study Sites (1)

Unknown Facility

Hanoi, Vietnam

Location

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Janssen-Cilag Ltd.,Thailand Clinical Trial

  Janssen-Cilag Ltd.,Thailand

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 4, 2013
• Study Start: March 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 15, 2013

Record last verified: 2013-04

Locations

VN (1)