A 4-Arm Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

Phase 2

Completed

Interventions: Other: Vehicle
Drug: RT001 Botulinum toxin type A (Dose A)
Drug: RT001 Botulinum Toxin Type A (Dose B)
Drug: Placebo

Brief Summary: The purpose of this study is to find out if an investigational drug, called RT001 Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called lateral canthal lines, also known as crow's feet wrinkles.

Detailed Description: RT001, a new drug, may be effective for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study, researchers want to find out if RT001 is more effective than three comparator groups by examining the effect on the improvement of crow's feet by both the patient and physician.

Recruitment & Eligibility

Inclusion Criteria

Written informed consent including authorization to release health information
Female or male, 18 to 65 years of age and in good general health
Willing and able to follow study instructions and likely to complete all study requirements
Moderate to severe lateral canthal lines (crow's feet wrinkles)

Exclusion Criteria

Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
Muscle weakness or paralysis, particularly in the area receiving study treatment
Active disease or irritation at the treatment areas including the eye and the skin
Pregnant, nursing, or planning a pregnancy during the study; or is a women of child bearing potential (WOCBP) but is not willing to use an effective method of birth control
Previous participation in a RT001 clinical study

Arm && Interventions

Group	Intervention	Description
Dose C	Vehicle	Vehicle Control
RT001 Botulinum toxin Type A (Dose A)	RT001 Botulinum toxin type A (Dose A)	RT001 (Botulinum toxin Type A)
RT001 Botulinum toxin type A (Dose B)	RT001 Botulinum Toxin Type A (Dose B)	RT001 (Botulinum Toxin Type A)
Dose D	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Subject improvement based in investigator assessment	Week 4	The number of subjects who show improvement based on the investigator global assessment

Secondary Outcome Measures

Name	Time	Method
Subject Improvement Based on investigator and patient assessments	Week 4	The number of subjects who show improvement based on the investigator global and patient assessments