A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: Clobetasol propionate cream; Drug: Betamethasone dipropionate cream; Drug: Glaxal Base cream vehicle; Drug: Pimecrolimus cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT02376049

EXP-1184

Details and patient eligibility

About

An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults with Mild to Moderate Atopic Dermatitis.

Full description

Multi-center, prospective, randomized, vehicle-controlled, investigator-blinded, stable lesion design.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject with mild to moderate AD
• Four comparable TAs
• TSS of at least 5 on all TAs
• Difference in TSS not greater than 2 between the TAs
• Sign score erythema ≥ 2 between the TAs
• TAs should be at least 2 cm apart

Exclusion criteria

• Investigator's opinion
• Fitzpatrick skin type >5
• Topical (i.e. on the TAs) treatment with prohibited medications
• Systemic treatment with prohibited medications
• Phototherapy within prohibited timeframe
• Use of emollients within prohibited timeframe

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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30 participants in 4 patient groups, including a placebo group

Pimecrolimus cream

Active Comparator group

Description:

Pimecrolimus 1% cream once daily for 14 days

Treatment:

Drug: Pimecrolimus cream

Betamethasone dipropionate cream

Active Comparator group

Description:

Betamethasone dipropionate 0.05% cream once daily for 14 days

Treatment:

Drug: Betamethasone dipropionate cream

Clobetasol propionate cream

Active Comparator group

Description:

Clobetasol propionate 0.05% cream once daily for 14 days

Treatment:

Drug: Clobetasol propionate cream

Glaxal Base cream vehicle

Placebo Comparator group

Description:

Glaxal Base cream vehicle once daily for 14 days

Treatment:

Drug: Glaxal Base cream vehicle