Botox Cosmetic and the Young Patient With Glabellar Furrows

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if consistent treatment with Botox will lead to longer lasting effects. Botox is an injectable liquid that is approved by the U.S. Food and Drug Administration to reduce wrinkles on the forehead in the area between the eyebrows. In this study a different dosing schedule of Botox injections will be used to see if the effects of the Botox treatment last longer than the effects of the standard injection regimen.

Official Title
-----------------
Botox Cosmetic and the Young Patient With Glabellar Furrows

Conditions
-----------------
Glabellar Furrows

Intervention / Treatment
-----------------
* Drug: Botox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Fitzpatrick Skin Types I-III Between 30 and 50 years of age At least moderate severity at maximum frown Exclusion Criteria: Prior botulinum toxin treatment Any disorder (such as myasthenia gravis, Eaton-Lambert syndrome) or agent (such as aminoglycoside antibiotics) that might interfere with neuromuscular function Any other condition or situation that might put the subject at significant risk, confound the study results (such as significant pre-existing brow or eyelid ptosis) Allergy or sensitivity to any study component Participation in another clinical study within 30 days of the study start date Are planning other facial cosmetic procedures during the study period, or are pregnant, breastfeeding, or planning a pregnancy during the study.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botox<br>Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups | Drug: Botox<br>* Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the Facial Wrinkle Scale | Four-point validated facial wrinkle scale (FWS) Minimum score = 0 (no wrinkles) Maximum score = 3 (deep wrinkles) Baseline to 20 months is the active injection phase 20 months to 26 months is the follow-up phase | 26 months | 
| Patient Assessed Frown-line Improvement | Four-point satisfaction scale Neutral = 0 (minimum score) Somewhat satisfied = 1 Definitely satisfied = 2 Greatly satisfied = 3 Couldn't be more satisfied = 4 (maximum score) Baseline to 20 months is the active injection phase 20 months to 26 months is the follow-up phase | 20 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glabellar lines of moderate severity at maximum frown