Facial RhytidsPhase 2NCT02907268

Botulinum Toxin A Single Blind Split-Face Randomized Pilot Study

A Phase 2 study testing onabotulinumtoxinA and abobotulinumtoxinA in people with Facial Rhytids, run by ICLS Dermatology & Plastic Surgery.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 65 years
Conditions the study is for: Facial Rhytids
What is being tested?: onabotulinumtoxinA and abobotulinumtoxinA
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: No sites listed yet
Study dates: Sep 2013to Jan 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Female subjects between ages of 35 to 65 years (inclusive) who exhibit static wrinkles in the following areas: glabella (forehead frowns), periorbital area (crows feet). Static wrinkles in additional areas of the face are also acceptable.
Subject is willing to maintain the same skin care regimen throughout the study and has already maintained this skin care regime for 4 weeks prior to baseline.
The subject is able to comply with study procedures and instructions and is committed to attend all study visits within the given timelines.
Subject is judged to be a good candidate by study nurse upon identification of dynamic and/or static wrinkles in the areas of movement, and with a moderate amount of skin laxity.
Subject is willing to use contraception
A signed informed consent form by a subject able to give consent, prior to any study procedures are performed.

Who cannot join

Sensitivity and/or contraindications to botulinum toxin A other ingredients contained in the botulinum toxin A products.
Any medical condition, in the opinion of the investigator, that would interfere with safety or any study procedures (e.g. auto-immune disease, history of severe allergies, hypertrophic scars, immunotherapeutic treatment, inflammatory or infectious complaints at injection sites, unable to give consent)
Treatment with botulinum toxin A injections in the neck or face within 1 year of baseline treatment
Treatment with facial fillers less than 1 year prior to baseline
Females of childbearing potential who are pregnant, breastfeeding or plan to get pregnant during the course of the study.
Previous treatment with Lasers, Ultrasound Technology or Radio Frequency on the face and/or neck within 1 year prior to baseline.

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Treatment with Accutane (isotretinoin) or other oral medications for acne during 1 year prior to baseline.
The use of anti-aging products containing retinol
Known allergy to cow's milk protein

About this study

Official title: A Single Blind, Split-Face, Randomized, Pilot Study Comparing the Effects of Intradermal and Intramuscular Injection of Two Commercially Available Botulinum Toxin A Formulas to Reduce Signs of Facial Aging

A 16-week single-blind, split-face, randomized study. Each patient served as their own control, receiving onabotulinumtoxinA and abobotulinumtoxinA randomized to either the left or right side of the face. Patients received intradermal BTXA injections at week 0 and intramuscular BTXA injections at week 2. The objective is to examine the effectiveness of intradermal botulinum toxin type A (BTXA) injection in improving skin texture and midface lift while reducing pore size and sebum production, as well as investigate the differences in effectiveness between onabotulinumtoxinA and abobotulinumtoxinA using intradermal and intramuscular injection methods.

Conditions: Facial Rhytids
Being tested: onabotulinumtoxinA, abobotulinumtoxinA
Keywords: botulinum toxin type A, intradermal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

onabotulinumtoxinADrug
Also called Botox
OnabotulinumtoxinA (Botox; Allergan) was approved by the FDA in 2002. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered as per normal practice.
abobotulinumtoxinADrug
Also called Dysport
AbobotulinumtoxinA (Dysport; Galderma) 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 as per normal practice.

Study groups in NCT02907268
Study group	Role	What they receive
Treatment Arm A	Active comparator	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. Receives: Drug: onabotulinumtoxinA; Drug: abobotulinumtoxinA
Treatment Arm B	Active comparator	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. Receives: Drug: onabotulinumtoxinA; Drug: abobotulinumtoxinA

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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.
Measured: Baseline and 2 weeks
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
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.
Measured: Baseline and 4 weeks
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
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.
Measured: Baseline and 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Jan 2014

First posted20 Sep 2016 (estimated)
Study startSep 2013
Primary completionJan 2014
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Facial RhytidsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02907268
Sponsor's protocol ID: ICLS-06-2013
Status last verified: Sep 2017
First submitted: 8 Sep 2016
Last updated: 13 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Photographs of individual participants are included in presentations and publications. Consent to reproduce photographs has been obtained from all participants. No other IPD is planned to be shared unless requested.

Publications

Sapra P, Demay S, Sapra S, Khanna J, Mraud K, Bonadonna J. A Single-blind, Split-face, Randomized, Pilot Study Comparing the Effects of Intradermal and Intramuscular Injection of Two Commercially Available Botulinum Toxin A Formulas to Reduce Signs of Facial Aging. J Clin Aesthet Dermatol. 2017 Feb;10(2):34-44. Epub 2017 Feb 1.
PubMed 28367260

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Safety and Efficacy of 2910 nm Fiber Laser Resurfacing and Laser-Coring
Rhytids, Skin Laxity
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A Non-Interventional PMCF Study Evaluating Croma Revitalis for the Correction of Fine Lines
Lateral Canthal Lines (LCL), Perioral Rhytids
Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Dermal Fillers, Cheek Augmentation
Active, not recruitingObservational study
Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
Facial Aging, Skin Rejuvenation
Active, not recruiting
RHA® Redensity With New Anesthetic Agent Perioral Rhytids (PAS)
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All Facial Rhytids trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Blind, Split-Face, Randomized, Pilot Study Comparing the Effects of Intradermal and Intramuscular Injection of Two Commercially Available Botulinum Toxin A Formulas to Reduce Signs of Facial Aging
ClinicalTrials.gov ID: NCT02907268
Acronym / sponsor ID: ICLS-06-2013
Conditions: Facial Rhytids
Keywords: botulinum toxin type A, intradermal
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: ICLS Dermatology & Plastic SurgeryUniversity, hospital or other
Study start: Sep 2013
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 20 Sep 2016 (estimated)
Results: Posted 13 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Treatment Arm A	Active comparator	Drug: onabotulinumtoxinA, Drug: abobotulinumtoxinAThe 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.
Treatment Arm B	Active comparator	Drug: onabotulinumtoxinA, Drug: abobotulinumtoxinAThe 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.

Who may qualify

Ages: 35 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Female subjects between ages of 35 to 65 years (inclusive) who exhibit static wrinkles in the following areas: glabella (forehead frowns), periorbital area (crows feet). Static wrinkles in additional areas of the face are also acceptable.
Subject is willing to maintain the same skin care regimen throughout the study and has already maintained this skin care regime for 4 weeks prior to baseline.
The subject is able to comply with study procedures and instructions and is committed to attend all study visits within the given timelines.
Subject is judged to be a good candidate by study nurse upon identification of dynamic and/or static wrinkles in the areas of movement, and with a moderate amount of skin laxity.
Subject is willing to use contraception

Key exclusion criteria (9 listed)

Sensitivity and/or contraindications to botulinum toxin A other ingredients contained in the botulinum toxin A products.
Any medical condition, in the opinion of the investigator, that would interfere with safety or any study procedures (e.g. auto-immune disease, history of severe allergies, hypertrophic scars, immunotherapeutic treatment, inflammatory or infectious complaints at injection sites, unable to give consent)
Treatment with botulinum toxin A injections in the neck or face within 1 year of baseline treatment
Treatment with facial fillers less than 1 year prior to baseline
Females of childbearing potential who are pregnant, breastfeeding or plan to get pregnant during the course of the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
onabotulinumtoxinAAlso: BotoxOnabotulinumtoxinA (Botox; Allergan) was approved by the FDA in 2002. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered as per normal practice.	Drug	Treatment Arm A, Treatment Arm B
abobotulinumtoxinAAlso: DysportAbobotulinumtoxinA (Dysport; Galderma) 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 as per normal practice.	Drug	Treatment Arm A, Treatment Arm B

Primary outcome

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
Time frame: Baseline and 2 weeks
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.
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
Time frame: 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.
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
Time frame: 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.

Results and safety

Results posted to the registry on 13 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Arm A	5	5
Treatment Arm B	5	5

Primary outcome: 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

Time frame: Baseline and 2 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Arm 1 n = 10
Value	-0.21 (0.39459)

Arm 1: p <0.05, Wilcoxon (Mann-Whitney)

Primary outcome: 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

Time frame: Baseline and 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Arm 1 n = 10
Value	-0.36 (0.419042)

Arm 1: p <0.05, Wilcoxon (Mann-Whitney)

Primary outcome: 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

Time frame: Baseline and 16 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Arm 1 n = 10
Value	-0.3889 (0.440262)

Arm 1: p <0.05, Wilcoxon (Mann-Whitney)

Adverse events

Time frame: 4 months (September 2013-January 2015). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Arm A	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Treatment Arm B	0 of 5 (0%)	5 of 5 (100%)	0 of 5

Limitations and caveats (from the sponsor): Limitations include small sample size and not having objective assessments. Insignificant p value could mean no difference detected or the sample was too small to detect difference. Blinded assessor made subjective assessments based on the photos.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28367260Sapra P, Demay S, Sapra S, Khanna J, Mraud K, Bonadonna J. A Single-blind, Split-face, Randomized, Pilot Study Comparing the Effects of Intradermal and Intramuscular Injection of Two Commercially Available Botulinum Toxin A Formulas to Reduce Signs of Facial Aging. J Clin Aesthet Dermatol. 2017 Feb;10(2):34-44. Epub 2017 Feb 1.
Individual participant dataSharing planned: Yes. Photographs of individual participants are included in presentations and publications. Consent to reproduce photographs has been obtained from all participants. No other IPD is planned to be shared unless requested.

Related trials for Facial Rhytids

Active, not recruiting
Safety and Efficacy of 2910 nm Fiber Laser Resurfacing and Laser-Coring
Rhytids, Skin Laxity
Active, not recruitingObservational study
A Non-Interventional PMCF Study Evaluating Croma Revitalis for the Correction of Fine Lines
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Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
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Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
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RHA® Redensity With New Anesthetic Agent Perioral Rhytids (PAS)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sheetal Sapra, MD, FRCPC principal investigator

ICLS Dermatology & Plastic Surgery

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing onabotulinumtoxinA and abobotulinumtoxinA in people with Facial Rhytids, run by ICLS Dermatology & Plastic Surgery.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline and 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02907268, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.