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

NCT01828879 | Completed Phase 4

• 2 other identifiers: CR017833R098924ADM4006
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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 adult participants.

Conditions

Dermatitis, Atopic

Keywords

Dermatitis, Atopic; Tacrolimus

Outcome Measures

Primary Outcomes (1)

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

  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

EXPERIMENTAL

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.

Drug: Tacrolimus

Interventions

Tacrolimus DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Ltd.,Thailand: lead

Study Sites (2)

Unknown Facility

Hanoi, Vietnam

Location

Unknown Facility

Hochiminh, Vietnam

Location

Related Links

• The efficacy and safety of tacrolimus ointment in Adult 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: March 21, 2013
• First Posted: April 11, 2013
• Study Start: November 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 11, 2013

Record last verified: 2013-04

Locations

VN (2)