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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00884234
Other study ID # RT001-CL011LCL
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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