A randomized, double-blind, parallell-group, controlled study of topical pentane-1,5-diol hydrogel in patients with impetigo

INTERVENTION: Product Name: Pentane‐1,5‐diol Pharmaceutical Form: Cutaneous paste INN or Proposed INN: pentane‐1,5‐diol CAS Number: 111‐29‐5 Current Sponsor code: P15D Other descriptive name: 1,5‐pentanediol Concentration unit: % (V/V) percent volume/volume Concentration type: range Concentration number: 0‐30 Pharmaceutical form of the placebo: Cutaneous paste Route of administration of the placebo: Cutaneous use CONDITION: Impetigo PRIMARY OUTCOME: Main Objective: To determine whether topical pentane‐1,5‐diol hydrogel is efficacious in patients with impetigo. Primary end point(s): ‐ Successfully treated cases with complete clinical improvement and no positive culture Secondary Objective: ‐ Reduction of impetigo; ‐ Recurrence of impetigo within 1 week; INCLUSION CRITERIA: ‐ Males and females; age 2 years or older ‐ Clinical diagnosis of impetigo Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range