A Phase 1 interventional study of MOB015B and MOB015B vehicle in Erythema, sponsored by Moberg Pharma AB. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Moberg Pharma AB · Phase 1, Interventional, and Other
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
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.
Exclusion Criteria:
Patches were applied to the infrascapular area
Drug: MOB015B
Patches were applied to the infrascapular area
Drug: MOB015B vehicle
Patches were applied to the infrascapular area
Drug: Negative irritant solution of 0.9% saline
Topcal formulation
Topcal formulation
Negative control
To determine the potential of MOB015B to induce sensitization by repeated topical application to the healthy skin of humans under controlled conditions.
Evaluation of dermal reactions at the application sites assessed clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation.
Time frame: 6 weeks
To assess safety
Evaluation of any adverse events (AEs) reported during the study.application to the healthy skin of humans.
Time frame: 6 weeks
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Moberg Pharma AB