NCT01828879

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

The Efficacy and Safety of Tacrolimus Ointment in Adult Patients With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Janssen-Cilag Ltd.,Thailand · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 participants with moderate to severe atopic dermatitis. Participants will be treated with 0.1 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 will consist of 6 visits: pre-study (optional), Baseline or Day 1, Weeks 1, 2, 3 and 4 (end-of-treatment). 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

Interventions

Type	Name	Description
DRUG	Tacrolimus	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.

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-06-01
• Completion: 2009-12-01
• First posted: 2013-04-11
• Last updated: 2013-04-11

Locations

2 sites across 1 country: Vietnam