NCT00534508 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Reitamo S, Mandelin J, Rubins A, Remitz A, Mäkelä M, Cirule K, Rubins S, Zigure S, Ho V, Dickinson J, Undre N
The pharmacokinetics of tacrolimus after first and repeated dosing with 0.03% ointment in infants with atopic dermatitis. Int J Dermatol. 2009 Apr;48(4):348-55. doi: 10.1111/j.1365-4632.2009.03853.x.
Undre NA, Moloney FJ, Ahmadi S, Stevenson P, Murphy GM
Skin and systemic pharmacokinetics of tacrolimus following topical application of tacrolimus ointment in adults with moderate to severe atopic dermatitis. Br J Dermatol. 2009 Mar;160(3):665-9. doi: 10.1111/j.1365-2133.2008.08974.x. Epub 2008 Dec 12.

A Study to Determine the Distribution of Tacrolimus in the Skin and the Systemic Pharmacokinetics of Tacrolimus in Adult Patients With Moderate to Severe Atopic Dermatitis Following First and Repeated Application of the Tacrolimus Ointment.

Details for clinical trial NCT00534508

Clinical trial NCT00534508 - References