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

Facial Wrinkles Clinical Trial

Official title:

A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Repeat Dose, Single Center Study to Evaluate the Efficacy and Safety 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: NCT00968942
• Other study ID #: RT001-CL015LCL
• Status: Completed
• Phase: Phase 2
• First received: August 28, 2009
• Last updated: October 25, 2013
• Start date: August 2009
• Est. completion date: October 2009

Study information

• Verified date: October 2013
• Source: Revance Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of 2 sequential doses of RT001 compared to placebo gel to treat moderate to severe lateral canthal lines in adults.

Description:

This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the efficacy and safety of a repeat application of RT001 compared to placebo gel in at least 36 subjects with moderate to severe lateral canthal lines (LCL). Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (active versus placebo). At least 36 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. There will be 18 subjects in each treatment group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• Female or male, 30 to 60 years of age

• Bilateral lateral canthal lines rated as moderate or severe

• Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening and through End of Study

• Women of childbearing potential must be practicing and willing to continue to use an effective method of birth control during the course of the study

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

• Muscle weakness or paralysis in the area receiving study treatment

• Active skin disease or irritation at the treatment areas

• Eyelid ptosis, excessive dermatochalasis, deep dermal scarring or inability to substantially lessen the lateral canthal lines to be treated by physically spreading them apart

• Use of prescription retinoid products during the past 3 months prior to Screening

• Chemical peel (medium depth or deeper) during the past 9 months prior to Screening

• Undergone any procedures that may affect the lateral canthal region such as:

periorbital surgery, brow lift or related procedures, laser skin resurfacing or soft tissue augmentation (upper half of face) during the past 12 months prior to Screening

• Screening electrocardiogram (ECG) that is abnormal or clinically significant or any history of hypokalemia, torsade de pointe, unstable angina, myocardial infarction or congestive heart failure or family history of prolonged QT

• Previous treatment with Botulinum Toxin Type A in the face area

• Previous treatment with greater than 200 U Botulinum Toxin Type A anywhere else in the body within the last 6 months prior to Screening

• Concurrent use of aminoglycoside antibiotics, or other agents that might interfere with neuromuscular transmission starting at Screening

• Use of a 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

• Clinically significant laboratory values at Screening

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crow's Feet
• Facial Wrinkles
• Lateral Canthal Lines

Intervention

Drug:
• Botulinum Toxin Type A
RT001 (Botulinum Toxin Type A Topical Gel) Dose A applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas
• Placebo
Placebo (Dose B) applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas

Locations

Country	Name	City	State
United States	Dermatology Research Institute, LLC.	Coral Gables	Florida

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 of Lateral Canthal Line-Rest Severity Scale of the LCA at Baseline compared to Week 8; incidence of treatment emergent AEs		Week 8	No
Secondary	The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line Severity at Smile and at Rest from Baseline to Weeks 2, 4, 6, 8; incidence of treatment emergent AEs		Weeks 2, 4, 6, 8	No