Trial Outcomes & Findings for Botulinum Toxin A Single Blind Split-Face Randomized Pilot Study (NCT NCT02907268)

Last Updated: 2017-10-13

Results Overview

Blinded assessments of overall change in facial wrinkles from baseline to week 2 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation \>2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Baseline and 2 weeks

Results posted on

2017-10-13

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm A The first treatment group received onabotulinumtoxinA (Botox) on the right side of their face and abobotulinumtoxinA (Dysport) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. onabotulinumtoxinA: OnabotulinumtoxinA (Botox; Allergan) was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead. abobotulinumtoxinA: AbobotulinumtoxinA (Dysport; Galderma) was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across	Treatment Arm B The second treatment group received abobotulinumtoxinA (Dysport) on the right side of their face and onabotulinumtoxinA (Botox) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. onabotulinumtoxinA: OnabotulinumtoxinA (Botox; Allergan) was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead. abobotulinumtoxinA: AbobotulinumtoxinA (Dysport; Galderma) was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Botulinum Toxin A Single Blind Split-Face Randomized Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm A n=5 Participants The first treatment group received onabotulinumtoxinA (Botox) on the right side of their face and abobotulinumtoxinA (Dysport) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. OnabotulinumtoxinA was approved by the FDA in 2002. AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered according to normal practice.	Treatment Arm B n=5 Participants The second treatment group received abobotulinumtoxinA (Dysport) on the right side of their face and onabotulinumtoxinA (Botox) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. OnabotulinumtoxinA was approved by the FDA in 2002. AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered according to normal practice.	Total n=10 Participants Total of all reporting groups
Age, Continuous	51.1 years n=5 Participants	51.1 years n=7 Participants	51.1 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Blinded assessment of facial rhytids	2.5 units on a scale n=5 Participants	2.8 units on a scale n=7 Participants	2.7 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 2 weeks

Outcome measures

Outcome measures
Measure	Arm 1 n=10 Participants Overall change in wrinkles score. This is calculated per patient, regardless of randomization.
Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 2 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs	-0.21 units on a scale Standard Deviation 0.39459

PRIMARY outcome

Timeframe: Baseline and 4 weeks

Blinded assessments of overall change in facial wrinkles from baseline to week 4 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation \>2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings.

Outcome measures

Outcome measures
Measure	Arm 1 n=10 Participants Overall change in wrinkles score. This is calculated per patient, regardless of randomization.
Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 4 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs	-0.36 units on a scale Standard Deviation 0.419042

PRIMARY outcome

Timeframe: Baseline and 16 weeks

Blinded assessments of overall change in facial wrinkles from baseline to week 16 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation \>2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings.

Outcome measures

Outcome measures
Measure	Arm 1 n=10 Participants Overall change in wrinkles score. This is calculated per patient, regardless of randomization.
Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 16 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs	-0.3889 units on a scale Standard Deviation 0.440262

Adverse Events

Treatment Arm A

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Treatment Arm B

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Arm A n=5 participants at risk The first treatment group received onabotulinumtoxinA (Botox) on the right side of their face and abobotulinumtoxinA (Dysport) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. onabotulinumtoxinA: OnabotulinumtoxinA was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead. abobotulinumtoxinA: AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead.	Treatment Arm B n=5 participants at risk The second treatment group received abobotulinumtoxinA (Dysport) on the right side of their face and onabotulinumtoxinA (Botox) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized. onabotulinumtoxinA: OnabotulinumtoxinA was approved by the FDA in 2002. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead. abobotulinumtoxinA: AbobotulinumtoxinA was approved by the FDA in 2009. Intervention administered by study nurse. Administered in a regular 1 cm2 grid across the cheeks and forehead.
Skin and subcutaneous tissue disorders Bruise	20.0% 1/5 • Number of events 1 • 4 months (September 2013-January 2015)	20.0% 1/5 • Number of events 1 • 4 months (September 2013-January 2015)
Skin and subcutaneous tissue disorders Drooping	20.0% 1/5 • Number of events 1 • 4 months (September 2013-January 2015)	80.0% 4/5 • Number of events 4 • 4 months (September 2013-January 2015)
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/5 • 4 months (September 2013-January 2015)	20.0% 1/5 • Number of events 1 • 4 months (September 2013-January 2015)
Skin and subcutaneous tissue disorders Face flushed	0.00% 0/5 • 4 months (September 2013-January 2015)	20.0% 1/5 • Number of events 1 • 4 months (September 2013-January 2015)
Nervous system disorders Pain during injection	0.00% 0/5 • 4 months (September 2013-January 2015)	20.0% 1/5 • Number of events 1 • 4 months (September 2013-January 2015)
Skin and subcutaneous tissue disorders Acne breakout	0.00% 0/5 • 4 months (September 2013-January 2015)	20.0% 1/5 • Number of events 1 • 4 months (September 2013-January 2015)
Skin and subcutaneous tissue disorders Welt on forehead	20.0% 1/5 • Number of events 1 • 4 months (September 2013-January 2015)	20.0% 1/5 • Number of events 1 • 4 months (September 2013-January 2015)
Skin and subcutaneous tissue disorders Stinging sensation on face	0.00% 0/5 • 4 months (September 2013-January 2015)	20.0% 1/5 • Number of events 1 • 4 months (September 2013-January 2015)
Nervous system disorders Itchiness	20.0% 1/5 • Number of events 1 • 4 months (September 2013-January 2015)	0.00% 0/5 • 4 months (September 2013-January 2015)
Skin and subcutaneous tissue disorders Left cheek looks more full	20.0% 1/5 • Number of events 1 • 4 months (September 2013-January 2015)	0.00% 0/5 • 4 months (September 2013-January 2015)
Nervous system disorders Tension headache	0.00% 0/5 • 4 months (September 2013-January 2015)	20.0% 1/5 • Number of events 1 • 4 months (September 2013-January 2015)
Musculoskeletal and connective tissue disorders Worsening inflammation at sacroiliac joint	0.00% 0/5 • 4 months (September 2013-January 2015)	20.0% 1/5 • Number of events 1 • 4 months (September 2013-January 2015)
Immune system disorders Cold	0.00% 0/5 • 4 months (September 2013-January 2015)	20.0% 1/5 • Number of events 1 • 4 months (September 2013-January 2015)
Nervous system disorders Numbness on forehead	0.00% 0/5 • 4 months (September 2013-January 2015)	20.0% 1/5 • Number of events 1 • 4 months (September 2013-January 2015)

Additional Information

Shantel Demay

ICLS

Phone: 905-842-2262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place