Study Evaluating the Safety, Tolerability, PK, and Activity of Topical ATx201 Gel in Outpatients With Impetigo

UNION Therapeutics

Status and phase: Completed; Phase 2

Conditions: Impetigo

Treatments: Other: ATx201 GEL Vehicle; Drug: ATx201

Study type: Interventional

Funder types: Industry

Identifiers

NCT03429595

ATx201-004

Details and patient eligibility

About

This is a Phase 2 study evaluating the safety, tolerability, systemic exposure, and activity of topical ATx201 GEL (2% and 4%) treatment for 1, 2, or 5 days in outpatients with primary nonbullous or bullous impetigo.

Enrollment: 210 patients

Sex: All

Ages: 9 months to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of primary nonbullous or bullous impetigo
• affected area comprising 1 to 100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area.
• target area has total SIRS score of at least 3, including pus/exudate of at least 1
• normally active and otherwise in good health by medical history and physical examination

Exclusion criteria

• has a pre-existing skin condition or skin trauma with clinical evidence of secondary infection
• has an infection that could not be appropriately treated with a topical antibiotic or severe manifestation of impetigo warranting systemic therapy
• clinically significant mental illness
• pregnant or breast-feeding
• recent history, or strong potential for, alcohol or substance abuse.
• skin condition that may interfere with the placement of study treatment or impede clinical evaluations
• receipt of systemic drugs that affect the immune system within the past 3 months
• receipt of any topical medication on the regions to be treated or topical antibiotics used for nasal decolonization within the past 24 hours

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 5 patient groups, including a placebo group

Group 1: ATx201 GEL 2%

Experimental group

Treatment:

Drug: ATx201

Group 2: ATx201 GEL 4%

Experimental group

Treatment:

Drug: ATx201

Group 3: ATx201 GEL 4% plus vehicle

Experimental group

Treatment:

Drug: ATx201

Other: ATx201 GEL Vehicle

Group 4: ATx201 GEL 4% plus vehicle

Experimental group

Treatment:

Drug: ATx201

Other: ATx201 GEL Vehicle

Group 5: Vehicle

Placebo Comparator group

Treatment:

Other: ATx201 GEL Vehicle