Trial Outcomes & Findings for Lateral Canthal Rhytides With Medium Depth Chemical Peel With or Without Pretreatment With Botulinum Toxin A (NCT NCT01586819)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

26 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2017-09-11

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	12	14
Overall Study COMPLETED	11	14
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Lateral Canthal Rhytides With Medium Depth Chemical Peel With or Without Pretreatment With Botulinum Toxin A

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Botulinum Toxin n=11 Participants 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.	Chemical Peel Only n=14 Participants 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.	Total n=25 Participants Total of all reporting groups
Age, Continuous	47.3 Years STANDARD_DEVIATION 4.8 • n=5 Participants	51.9 Years STANDARD_DEVIATION 7.1 • n=7 Participants	49.8 Years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Twenty-six female subjects ages 30 to 75 years old were enrolled in this study.

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.

Outcome measures

Outcome measures
Measure	Botulinum Toxin n=11 Participants 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.	Chemical Peel Only n=14 Participants 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.
Posttreament Results of Chemical Peel if Botox A is Added as Pre-treatment	1 Units on a wrinkle severity scale Interval 0.0 to 1.0	2 Units on a wrinkle severity scale Interval 1.0 to 2.0

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Twenty-six female subjects ages 30 to 75 years old were enrolled in this study.

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.

Outcome measures

Outcome measures
Measure	Botulinum Toxin n=11 Participants 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.	Chemical Peel Only n=14 Participants 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.
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 Interval 2.0 to 2.0	1 Units on a wrinkle severity scale Interval 1.0 to 1.0

Adverse Events

Botulinum Toxin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chemical Peel Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rebecca Tung, M.D.

Loyola University Chicago

Phone: 708-216-8000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place