Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines

Revance Therapeutics

Status and phase: Completed; Phase 2

Conditions: Lateral Canthal Lines

Treatments: Other: Vehicle Control; Drug: RT001 (Botulinum Toxin Type A Topical Gel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00884234

RT001-CL011LCL

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of 2 sequential doses of RT001 compared to vehicle control following applications at Baseline (Day 0) and Week 2.

Full description

This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the safety and efficacy of repeat application of RT001 in at least 30 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (RT001 Dose A or vehicle control).

Enrollment: 30 patients

Sex: All

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Female/male ages 30 to 55
2. Bilateral lateral canthal lines rated as moderate or advanced.
3. Willing to refrain from any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at screening through Week 6.
4. Women of child baring potential must practice and be willing to continue to use an effective method of birth control.

Exclusion criteria

1. Muscle weakness or paralysis in the area receiving treatment.
2. Active skin disease or irritation at treatment areas.
3. Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to screening.
4. Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0).
5. Use of topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to screening and continuing through End of Study (Week 6).
6. Any abnormality on the electrocardiogram (ECG) at screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive hear failure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

RT001 (Botulinum Toxin Type A Topical Gel)

Treatment:

Drug: RT001 (Botulinum Toxin Type A Topical Gel)

2

Placebo Comparator group

Description:

Vehicle Control

Treatment:

Other: Vehicle Control