Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 793
Healthy volunteers: no

Brief summary:
The aim of this trial is to assess the efficacy of 0416 Ointment in the Treatment of Atopic Dermatitis.

Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 2 weeks.

Detailed description:

Arms:
arm 1: Test product that contains the active pharmaceutical ingredient arm 2: Reference product that contains active pharmaceutical ingredient arm 3: Placebo that contains no active pharmaceutical ingredient

Interventions: intervention 1: 0416 intervention 2: Vehicle of 0416 test product intervention 3: tacrolimus ointment 0.1%
Intervention descriptions: intervention 1: Topical 0416 test product applied twice daily for 2 weeks intervention 2: Vehicle of 0416 test product applied twice daily for 2 weeks intervention 3: Reference Product for 0416 test product. Apply twice daily for 2 weeks.

Protocol document: