Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Investigation of the Safety and Efficacy of Elidel® 1% Cream in Atopic Disease Modification, Assessed in a 3-year Randomized Double-blind Vehicle Controlled Phase to Evaluate Effects on Atopic Dermatitis in Infants, and a 2-3 Year Open-label Phase to Evaluate the Effect of Early Intervention Versus Delayed Intervention With Elidel® on the Incidence of Asthma in Children
Brief Summary: This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.


Options:
A: Arm Label: Roflumilast Cream 0.05%; Type: ACTIVE_COMPARATOR; Interventions: Drug: Roflumilast Cream 0.05% | Arm Label: Roflumilast Cream 0.15%; Type: ACTIVE_COMPARATOR; Interventions: Drug: Roflumilast Cream 0.15% | Arm Label: Vehicle Cream; Type: PLACEBO_COMPARATOR; Interventions: Drug: Vehicle Cream | Intervention Type: DRUG; Name: Roflumilast Cream 0.05%; Assigned to Arm(s): Roflumilast Cream 0.05% | Intervention Type: DRUG; Name: Roflumilast Cream 0.15%; Assigned to Arm(s): Roflumilast Cream 0.15% | Intervention Type: DRUG; Name: Vehicle Cream; Assigned to Arm(s): Vehicle Cream
B: Arm Label: Double Blind (DB): Vehicle BID; Type: PLACEBO_COMPARATOR; Interventions: Drug: Vehicle Cream BID | Arm Label: DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID; Type: ACTIVE_COMPARATOR; Interventions: Drug: Triamcinolone 0.1% Cream BID, Drug: Vehicle Cream BID | Arm Label: DB: Ruxolitinib 0.15% Once Daily (QD); Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib 0.15% Cream QD | Arm Label: DB: Ruxolitinib 0.5% QD; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib 0.5% Cream QD | Arm Label: DB: Ruxolitinib 1.5% QD; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib 1.5% Cream QD | Arm Label: DB: Ruxolitinib 1.5% BID; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib 1.5% Cream BID | Arm Label: Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID; Type: PLACEBO_COMPARATOR; Interventions: Drug: Ruxolitinib 1.5% Cream BID | Arm Label: OL: TAC BID/Vehicle BID to Ruxolitinib 1.5% BID; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ruxolitinib 1.5% Cream BID | Arm Label: OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib 1.5% Cream BID | Arm Label: OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib 1.5% Cream BID | Arm Label: OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib 1.5% Cream BID | Arm Label: OL: Ruxolitinib 1.5% BID to Ruxolitinib 1.5% BID; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib 1.5% Cream BID | Intervention Type: DRUG; Name: Ruxolitinib 0.15% Cream QD; Assigned to Arm(s): DB: Ruxolitinib 0.15% Once Daily (QD) | Intervention Type: DRUG; Name: Ruxolitinib 0.5% Cream QD; Assigned to Arm(s): DB: Ruxolitinib 0.5% QD | Intervention Type: DRUG; Name: Ruxolitinib 1.5% Cream QD; Assigned to Arm(s): DB: Ruxolitinib 1.5% QD | Intervention Type: DRUG; Name: Ruxolitinib 1.5% Cream BID; Assigned to Arm(s): DB: Ruxolitinib 1.5% BID, OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID, OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID, OL: Ruxolitinib 1.5% BID to Ruxolitinib 1.5% BID, OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID, OL: TAC BID/Vehicle BID to Ruxolitinib 1.5% BID, Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID | Intervention Type: DRUG; Name: Triamcinolone 0.1% Cream BID; Assigned to Arm(s): DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID | Intervention Type: DRUG; Name: Vehicle Cream BID; Assigned to Arm(s): DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID, Double Blind (DB): Vehicle BID
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: E6005 | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: E6005; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Pimecrolimus | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Corticosteroid | Intervention Type: DRUG; Name: Pimecrolimus; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Corticosteroid; Assigned to Arm(s): 2

Answer: D