A Dose Ranging Vehicle Controlled Study to Determine the Safety and Efficacy of Permethrin Foam, 5% and Permethrin Foam, 4% for the Treatment of Scabies

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine and compare the safety and efficacy of permethrin foam 4% and permethrin foam 5% with that of vehicle in subjects with scabies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mylan Inc.; Renaissance Pharma, Inc.
• Collaborators: DPT Laboratories, Ltd.; Vyne Therapeutics Inc.
• Treatments: Permethrin

Criteria

Inclusion Criteria:

• Clinical diagnosis of active scabies infection.

• Subject is in good general health with normal appearing skin in noninfested areas.

• Females must be post-menopausal, surgically sterile or use an effective method of birth control with a negative pregnancy test (10 years of age and older) at study start.

Exclusion Criteria:

• Subject is pregnant, lactating, or is planning to become pregnant during the study.

• Subject has used any ectoparasiticide within the three weeks prior to study start.

• Subject has signs of systemic infection or is receiving systemic therapy for an infectious disease.

• Subject has severe cutaneous bacterial or fungal infections requiring therapy or heavily crusted lesions consistent with Norwegian scabies.

• Subject is currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days prior to study start.

• Subject whose close personal contacts will not comply with standard of care for fomite management.