NCT06369675

Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design

A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Moberg Pharma AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design To evaluate the irritation potential of MOB015B on normal skin. Single center, randomized, controlled, evaluator blinded, within-subject comparison study

Detailed description

MOB015B is a newly developed topical solution for the treatment of nail fungus (onychomycosis) containing the active antifungal ingredient terbinafine. A This study investigates the irritation potential of MOB015B under standardized conditions compared with a known irritant (0.2% SLS) and an inert control (normal saline). Because MOB015B is formulated for topical use, it is necessary to determine the potential of this product to cause irritation after repeated topical application to the skin.

Conditions

• Erythema

Interventions

Type	Name	Description
DRUG	MOB015B	Topical formulation
DRUG	0.2% SLS	Positive control
DRUG	0.9% Saline	Negative control
DRUG	MOB015B vehicle	Topical formulation

Timeline

• Start date: 2017-10-19
• Primary completion: 2017-11-14
• Completion: 2017-11-14
• First posted: 2024-04-17
• Last updated: 2024-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study