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

Lateral Canthal Lines Clinical Trial

Official title:

A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Repeat Dose, Single Center Study to Evaluate the Safety and Efficacy of RT001, a Botulinum Toxin Type A Topical Gel, for the Treatment of Moderate to Severe Lateral Canthal Lines In Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884234
• Other study ID #: RT001-CL011LCL
• Status: Completed
• Phase: Phase 2
• Start date: February 2009
• Est. completion date: June 2009

Study information

• Verified date: August 2020
• Source: Revance Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lateral Canthal Lines

Intervention

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

Drug:
• RT001 (Botulinum Toxin Type A Topical Gel)
Two sequential doses of RT001 at Baseline (Day 0) and Week 2

Locations

Country	Name	City	State
United States	Suzanne Bruce & Associates / The Center for Skin Research	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Revance Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of subjects classified as exhibiting improvement via the Investigator Global Assessment from Baseline (Day 0) to End of Study (Week 6).		Baseline (Day 0) and Week 6
Primary	Incidence of treatment emergent AEs.		Baseline (Day 0) and Week 6