Glabellar Furrows
Conditions
Keywords
Glabellar lines of moderate severity at maximum frown
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.
Interventions
DRUGBotox
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
Sponsors
Allergan
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of the Facial Wrinkle Scale | 26 months | 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 |
| Patient Assessed Frown-line Improvement | 20 months | 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 |
Participant flow
Recruitment details
Recruited from medical practice and IRB approved media placement
Participants by arm
| Arm | Count |
|---|---|
| Botox 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
Botox: 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 | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Botox | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 50 Participants | — |
| Facial wrinkle scale | 2.78 units on a scale | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 50 participants | — |
| Sex: Female, Male Female | 50 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
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
Time frame: 20 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Patient Assessed Frown-line Improvement | Score 0 | 7 percentage of patients |
| Treatment | Patient Assessed Frown-line Improvement | Score 1 to 2.5 | 24 percentage of patients |
| Treatment | Patient Assessed Frown-line Improvement | Score 3 to 4 | 69 percentage of patients |
p-value: <0.0004Wilcoxon (Mann-Whitney)
Primary
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
Time frame: 26 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Reduction of the Facial Wrinkle Scale | Physician Rating | 1.86 units on a scale | Standard Deviation 0.65 |
| Treatment | Reduction of the Facial Wrinkle Scale | Subject Rating | 2.10 units on a scale | Standard Deviation 0.67 |
p-value: <0.001Wilcoxon (Mann-Whitney)