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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mylan Inc.
With
DPT Laboratories, Ltd.
Vyne Therapeutics Inc.
It is anticipated that a majority of subjects will require and receive a single treatment; however, those subjects not showing improvement at the follow-up visit 2 weeks after initial treatment will be treated a second time. Those subjects originally assigned to vehicle for the first treatment will receive a "re-treatment" with one of the active doses.
Age
0–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
