Conditions: Eczema
Keywords: eczema at least 3 patches of eczema
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 23
Healthy volunteers: no

Brief summary:
The primary objective of this clinical study is to determine whether occlusion of triamcinolone 0.1% cream (TAC) with hydrogel patch improves its efficacy in treating eczema. A secondary objective is to determine whether eczema improves under occlusion with hydrogel patch alone, without TAC.

Detailed description:
This will be a 6-week, open label, bilaterally-controlled single center study involving 30 subjects age 13 and older with eczema. The primary objective of this clinical study is to determine whether occlusion of triamcinolone 0.1% cream (TAC) used to treat eczema with hydrogel patch improves its efficacy. A secondary objective is to determine whether eczema improves under occlusion with hydrogel patch alone. All subjects will have 3 target lesions of similar severity followed throughout the study. Patients will apply hydrogel patch alone to the first lesion, TAC 0.1% cream to the second lesion, and TAC 0.1% cream occluded by hydrogel patch to the third lesion. All treatments are twice a day for a maximum of 4 weeks or until lesions are cleared. The modified Eczema Area and Severity Index (EASI) score will be used to evaluate each lesion.

Arms:
arm 1: This is a single arm study. Each subject will have 3 target lesions; one treated with TAC 0.1% cream and hydrogel patch (occlusion), the second treated with cream alone, and the third treated with occlusion alone.

Interventions: intervention 1: hydrogel patch intervention 2: Triamcinolone (TAC) 0.1% cream
Intervention descriptions: intervention 1: occlusion of eczema with a hydrogel patch composed of an adhesive, thin, flexible, hydrogel layer on an impermeable urethane surface. intervention 2: Triamcinolone Acetonide (triamcinolone acetonide cream) is a topical corticosteroid used as anti-inflammatory and antipruritic agent. Each gram of TAC Cream USP, 0.1% contains 1 mg Triamcinolone Acetonide (triamcinolone acetonide cream) in a cream base consisting of cetyl alcohol, glyceryl monostearate, cetyl esters wax, isopropyl palmitate, polysorbate-60, polysorbate-80, propylene glycol and purified water.

Protocol document: