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

NCT00968942 | Completed Phase 2

• 1 other identifier: RT001-CL015LCL
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lateral Canthal Lines; Crow's Feet; Facial Wrinkles

Keywords

Lateral Canthal Lines; Crow's Feet; Facial Wrinkles

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

Dose A

ACTIVE COMPARATOR

RT001

Drug: Botulinum Toxin Type A

Dose B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Botulinum Toxin Type A DRUG

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

Dose A

Placebo DRUG

Placebo (Dose B) applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas

Dose B

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Revance Therapeutics, Inc.: lead

Study Sites (1)

Dermatology Research Institute, LLC.

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Frederic S Brandt, M.D.

  Dermatology Research Institute, LLC.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2009
• First Posted: August 31, 2009
• Study Start: August 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: November 19, 2013

Record last verified: 2013-10

Locations

US (1)