Wrinkles
Conditions
Brief summary
This study is being done to find out if the use of botulinum toxin prior to a medium strength combination chemical peel (Jessner's peel followed by 35% Trichloroacetic acid peel) will improve the appearance of crow's feet wrinkles when compared to a chemical peel alone. Botulinum toxin type A is a purified substance, derived from a bacteria that block muscular nerve signals. Jessner's Peel, a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%), is a superficial chemical peel. These two products/procedures have been FDA approved to improve the appearance of facial wrinkles.
Detailed description
Wrinkling in the skin is caused by habitual facial expressions, aging, sun damage, smoking, poor hydration, and various other factors. There are two major types of wrinkles-dynamic and static. Dynamic wrinkles, which are due to excessive muscle activity, usually of the face, tend to disappear when you relax your facial muscles. The most common of these dynamic wrinkles are frown lines, forehead wrinkles, and eye wrinkles (or crow's feet). However, if the excessive muscle activity is carried on for too long, these do not disappear completely on relaxation, and are thus called static wrinkles. Static wrinkles are formed either by chronic excessive muscle activity or are due to the effects of age and gravity, with a loss of subcutaneous fat. Examples of static wrinkles are the nasolabial folds, which are the deep grooves running from the sides of the nose to the corners of the mouth.
Interventions
DRUGBotulinum Toxin
The botulinum toxin will be injected into the wrinkles crow's feet. The injections will take about 10 minutes to complete.
PROCEDUREChemical Peel Only
After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution \[a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%)\] will be applied to the entire face with a large cotton swab. The mixture will be left in place for a few minutes, and then the face will be wiped clean with water. Next, the TCA peel \[35% Trichloroacetic acid\] will be applied around the eyes. After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water. Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly.
Sponsors
Loyola University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 30 to 75 years old * In good health * Has static and dynamic lateral canthal wrinkles (crow's feet) * Has the willingness and the ability to understand and provide informed consent and communicate with the investigator
Exclusion criteria
* Pregnant or lactating * Has received the following treatments: * botulinum toxin injections in the past 6 months * ablative laser procedure in the past 6 months * radiofrequency device treatment in the past 6 months * ultrasound device treatment in the past 6 months * medium to deep chemical peel in the past 6 months * temporary soft tissue augmentation material in the past year * semi-permanent soft tissue augmentation material in the past 2 years * permanent soft tissue augmentation material * Is planning to receive within the next 3 months, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) * Has an active infection on their face (excluding mild acne * Has a history of neuromuscular disorders * Has an allergy to albumin * Has an allergy to Aquaphor AND petroleum jelly * Has a history of bleeding disorders * Is unable to understand the protocol or to give informed consent * Has a mental illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posttreament Results of Chemical Peel if Botox A is Added as Pre-treatment | Baseline and 12 weeks | The primary objective of this study is to determine if pre-treating the orbicularis oculi muscles with botulinum toxin A improves the results of medium depth chemical peels when treating lateral canthal rhytides. The primary dependent variable is the four-point Facial Wrinkle Severity Scale (FWSS): Grade 0 = no wrinkles; Grade 1 = mild wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wrinkles. |
| Change From Pre- to Post-treatment Scores of Chemical Peel if Botox A is Added as Pre-treatment | Baseline and 12 weeks | The primary objective of this study is to determine if there is a significant difference between the change from pre- to post-treatment scores on the facial wrinkle severity scale between the chemical peel control group and the chemical peel plus Botox A treatment group. The primary dependent variable is the four-point Facial Wrinkle Severity Scale (FWSS): Grade 0 = no wrinkles; Grade 1 = mild wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wrinkles. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin The botulinum toxin will be injected into the wrinkles. The injections will take about 10 minutes to complete. Five follow-up visits will be scheduled at 1-7 days, 7-10 days, 2.5-3 weeks, and 12-14 weeks. | 11 |
| Chemical Peel Only After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution \[a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%)\] will be applied to the entire face with a large cotton swab. The mixture will be left in place for a few minutes, and then the face will be wiped clean with water. Next, the TCA peel \[35% Trichloroacetic acid\] will be applied around the eyes. After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water. Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly. | 14 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Botulinum Toxin | Chemical Peel Only | Total |
|---|---|---|---|
| Age, Continuous | 47.3 Years STANDARD_DEVIATION 4.8 | 51.9 Years STANDARD_DEVIATION 7.1 | 49.8 Years STANDARD_DEVIATION 6.5 |
| Sex: Female, Male Female | 11 Participants | 14 Participants | 25 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 14 |
| other Total, other adverse events | 0 / 11 | 0 / 14 |
| serious Total, serious adverse events | 0 / 11 | 0 / 14 |
Outcome results
Primary
Change From Pre- to Post-treatment Scores of Chemical Peel if Botox A is Added as Pre-treatment
The primary objective of this study is to determine if there is a significant difference between the change from pre- to post-treatment scores on the facial wrinkle severity scale between the chemical peel control group and the chemical peel plus Botox A treatment group. The primary dependent variable is the four-point Facial Wrinkle Severity Scale (FWSS): Grade 0 = no wrinkles; Grade 1 = mild wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wrinkles.
Time frame: Baseline and 12 weeks
Population: Twenty-six female subjects ages 30 to 75 years old were enrolled in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Botulinum Toxin | Change From Pre- to Post-treatment Scores of Chemical Peel if Botox A is Added as Pre-treatment | 2 Units on a wrinkle severity scale |
| Chemical Peel Only | Change From Pre- to Post-treatment Scores of Chemical Peel if Botox A is Added as Pre-treatment | 1 Units on a wrinkle severity scale |
Comparison: The null hypothesis was that subjects receiving Botox A as an added pre-treatment would have higher difference scores, pre- to post-treatment, on the facial wrinkle severity scale suggesting a more pronounced effect of the chemical peel in combination with the Botox A therapy.p-value: 0.001Wilcoxon (Mann-Whitney)
Primary
Posttreament Results of Chemical Peel if Botox A is Added as Pre-treatment
The primary objective of this study is to determine if pre-treating the orbicularis oculi muscles with botulinum toxin A improves the results of medium depth chemical peels when treating lateral canthal rhytides. The primary dependent variable is the four-point Facial Wrinkle Severity Scale (FWSS): Grade 0 = no wrinkles; Grade 1 = mild wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wrinkles.
Time frame: Baseline and 12 weeks
Population: Twenty-six female subjects ages 30 to 75 years old were enrolled in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Botulinum Toxin | Posttreament Results of Chemical Peel if Botox A is Added as Pre-treatment | 1 Units on a wrinkle severity scale |
| Chemical Peel Only | Posttreament Results of Chemical Peel if Botox A is Added as Pre-treatment | 2 Units on a wrinkle severity scale |
Comparison: The null hypothesis was that subjects receiving Botox A as an added pre-treatment would have lower scores on the facial wrinkle severity scale post-treatment.p-value: 0.002Wilcoxon (Mann-Whitney)