NCT06369727

Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design

A Randomized, Controlled Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Moberg Pharma AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A Randomized, Controlled Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design To evaluate the sensitization potential

Detailed description

MOB015B is a topical solution for the treatment of nail fungus (onychomycosis) containing the active antifungal ingredient terbinafine. Terbinafine is a well-known antifungal agent that has been widely used for decades for both in topical and oral preparations and is regarded as an effective treatment of dermatophyte infections. In a phase II study, MOB015B was found to be efficacious and safe in the topical treatment of distal subungual onychomycosis. This Phase 1 study will assess the sensitization potential of MOB015B.

Conditions

• Erythema

Interventions

Type	Name	Description
DRUG	MOB015B	Topcal formulation
DRUG	MOB015B vehicle	Topcal formulation
DRUG	Negative irritant solution of 0.9% saline	Negative control

Timeline

• Start date: 2017-10-15
• Primary completion: 2018-02-15
• Completion: 2018-02-15
• First posted: 2024-04-17
• Last updated: 2024-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study