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

NCT ID: NCT00884234

Last Updated: 2020-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-06-30

Brief Summary

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.

Detailed 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).

Conditions

Lateral Canthal Lines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

RT001 (Botulinum Toxin Type A Topical Gel)

Group Type: EXPERIMENTAL

RT001 (Botulinum Toxin Type A Topical Gel)

Intervention Type: DRUG

Two sequential doses of RT001 at Baseline (Day 0) and Week 2

2

Vehicle Control

Group Type: PLACEBO_COMPARATOR

Vehicle Control

Intervention Type: OTHER

Two sequential doses of Vehicle Control at Baseline (Day 0) and Week 2

Interventions

Vehicle Control

Two sequential doses of Vehicle Control at Baseline (Day 0) and Week 2

Intervention Type: OTHER

RT001 (Botulinum Toxin Type A Topical Gel)

Two sequential doses of RT001 at Baseline (Day 0) and Week 2

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Revance Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzanne Bruce, MD

Role: PRINCIPAL_INVESTIGATOR

The Center for Skin Research

Locations

Suzanne Bruce & Associates / The Center for Skin Research

Houston, Texas, United States

Countries

United States

Other Identifiers

RT001-CL011LCL

Identifier Type: -

Identifier Source: org_study_id