Conditions: Dermatitis, Atopic Eczema, Atopic Skin Diseases, Eczematous
Keywords: Impetiginous
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3
Healthy volunteers: no

Brief summary:
This is a parallel-group, randomized, active-controlled, double-blind, Phase 4 trial comparing three creams in the treatment of impetiginous eczema:

* Arm A: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)
* Arm B: Combination of betamethasone diproprionate cream and gentamicin sulfate cream
* Arm C: Betamethasone diproprionate cream

At 7 sites, in Portugal, a total of 207 subjects will be randomized using a 1:1:1 randomization ratio to receive one of the three possible treatments for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. Assessments will be made of level of improvement of the target area in each treatment group, number of days for total remission, and safety profile.

Note: This study was terminated early due to lack of recruitment (only 3 of the 207 planned participants were enrolled). Statistical analyses were not performed.

Further, 7 sites were planned, but only 4 sites were approved out of which 3 sites were initiated.

Detailed description:

Arms:
arm 1: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) arm 2: Combination of betamethasone diproprionate cream and gentamicin sulfate cream arm 3: Betamethasone diproprionate cream

Interventions: intervention 1: Cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) intervention 2: Cream (betamethasone diproprionate and gentamicin) intervention 3: Cream (betamethasone diproprionate)
Intervention descriptions: intervention 1: Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% cream applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. intervention 2: Betamethasone diproprionate 0.05% and gentamicin sulfate 0.1% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. intervention 3: Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.

Protocol document: