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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lateral Canthal Lines Crow's Feet Facial Wrinkles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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RT001 Botulinum toxin Type A (Dose A)

RT001 (Botulinum toxin Type A)

Group Type EXPERIMENTAL

RT001 Botulinum toxin type A (Dose A)

Intervention Type DRUG

RT001 Botulinum Toxin Type A (Dose A)

RT001 Botulinum toxin type A (Dose B)

RT001 (Botulinum Toxin Type A)

Group Type EXPERIMENTAL

RT001 Botulinum Toxin Type A (Dose B)

Intervention Type DRUG

RT001 Botulinum Toxin Type A (Dose B)

Dose C

Vehicle Control

Group Type OTHER

Vehicle

Intervention Type OTHER

Vehicle Control

Dose D

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Comparator

Interventions

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RT001 Botulinum toxin type A (Dose A)

RT001 Botulinum Toxin Type A (Dose A)

Intervention Type DRUG

RT001 Botulinum Toxin Type A (Dose B)

Intervention Type DRUG

Vehicle

Vehicle Control

Intervention Type OTHER

Placebo

Placebo Comparator

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes