Edematous Fibrosclerotic PanniculopathyPhase 1NCT01518907

The Safety, Effectiveness, and Pharmacokinetics of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)

A Phase 1 study testing COLLAGENASE CLOSTRIDIUM HISTOLYTICUM in people with Edematous Fibrosclerotic Panniculopathy and Cellulite, run by Endo USA Inc., a Keenova Therapeutics Company at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

This study will evaluate the safety, effectiveness, pharmacokinetics, and immunogenicity of AA4500 at increasing doses and concentrations in the treatment of adult women with cellulite. Read more about this study

Who is it for?: Ages 21 to 60 years, women only
Conditions the study is for: Edematous Fibrosclerotic Panniculopathy, Cellulite
What is being tested?: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 99 participants
Where: 1 siteUnited States
Study dates: Jan 2012to Feb 2013
Phase: Phase 1
Are there results?: None posted in the registry

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 21 to 60 years
Women only
No healthy volunteers
Adult

Who may be able to join

Be a female and be ≥ 21 years of age and ≤ 60 years of age
Have a skin type classification of I through V according to the Fitzpatrick scale
Have EFP within the posterolateral thigh(s) and/or buttock(s) for at least 12 months before the screening visit
Have a photonumeric cellulite severity scale (CSS) score of ≥ 7 representing moderate to severe cellulite severity within the right or left buttock or the right or left posterolateral thigh (selected quadrant)
Have an area of EFP within the selected quadrant that is at least 8 cm x 10 cm (ie, target EFP area) and is suitable for treatment:
The target EFP area must be located on the posterolateral thigh or within the buttock and does not involve the gluteal fold

Show all 15Show fewer

The target EFP area must be evident when the subject is standing, without the use of any manipulation such as skin pinching or muscle contraction (ie, CSS Classification E score of 2 or 3) at screening and before injection
Have a Body Mass Index (BMI) between 20.0 and 33.0 kg/m2, and intends to maintain stable body weight throughout the duration of the study (a variation of ≤5% from baseline body weight is permitted)
Be willing to refrain from using artificial tanning devices and lotions during the 2-week period before screening and throughout the duration of the study
Be willing to apply sunscreen with sun protection factor (SPF) ≥15 to the selected quadrant before each exposure to the sun while participating in the study (ie, screening through Day 90)
Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening
Have a negative urine pregnancy test at screening and before injection of AA4500 and be using an effective contraception method (ie, abstinence, intrauterine device [IUD], hormonal [estrogen/progestin] contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for the duration of the study, or be surgically sterile, or be a postmenopausal female (no menses for at least 1 year or hysterectomy)
Be willing and able to cooperate with the requirements of the study including requirements during the confinement period and throughout the study
Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC). The subject must also sign an authorization form to allow disclosure of her protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution
Be able to complete and understand the various rating instruments in English

Who cannot join

Has any of the following conditions:
Thyroid disease, unless controlled with medication for ≥ 6 months
Uncontrolled diabetes mellitus, as determined by the investigator
Uncontrolled hypertension, as determined by the investigator
Vascular disorder (eg, phlebitis or varicose veins) in area to be treated
Lipedema or a lymphatic disorder

Show all 32Show fewer

History of lower extremity thrombosis or post-thrombosis syndrome
Documented autoimmune disorder such as lupus erythematosus, rheumatoid arthritis
Inflammation or active infection in area to be treated
Cutaneous alteration in area to be treated
Rash, eczema, psoriasis, or skin cancer in the area to be treated
History of keloidal scarring or abnormal wound healing
Coagulation disorder; taking an anticoagulant (except for ≤ 150 mg aspirin daily) up to 7 days prior to injection day
Known active hepatitis B or C (history of hepatitis A is permitted)
Known immune deficiency disease or a positive test for human immunodeficiency virus (HIV)
Other significant conditions including body dysmorphic disorder, which in the investigator's opinion would make the subject unsuitable for enrollment in the study
Has used any of the following for the treatment of EFP on the legs or buttock or intends to use any of the following at any time during the study:
Liposuction at any time before injection of AA4500
Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or surgery (including subcision) within 12 months before injection of AA4500
Endermologie or similar treatments within 6 months before injection of AA4500
Massage therapy within 3 months before injection of AA4500
Creams to prevent or mitigate EFP within 2 weeks before injection of AA4500
Has a tattoo in the quadrant selected for treatment
Is presently nursing a baby or providing breast milk for a baby
Intends to become pregnant during the study
Intends to initiate an intensive sport or exercise program during the study
Has an unrealistic expectation for treatment outcome, as determined by the investigator
Has a positive alcohol breath test and/or a positive urine drug screen for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and/or propoxyphene at screening or Day -1
Has received an investigational drug or treatment within 30 days before injection of AA4500
Has a known systemic allergy to collagenase or any other excipient of AA4500
Has received any collagenase treatments within 30 days before treatment
Has, at any time, received AA4500

Trial locations and contacts

1 site in 1 country.

United States1 site

SNBL Clinical Pharmacology Center, Inc
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: A Phase 1b, Open-label, Dose-escalation Study of the Safety, Effectiveness, and Pharmacokinetics of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy Commonly Known as Cellulite

This study will evaluate the safety, effectiveness, pharmacokinetics, and immunogenicity of AA4500 at increasing doses and concentrations in the treatment of adult women with cellulite.

Conditions: Edematous Fibrosclerotic Panniculopathy, Cellulite
Being tested: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
Keywords: cellulite, Xiaflex
Medical subject headings: Cellulite

What participants receive

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

COLLAGENASE CLOSTRIDIUM HISTOLYTICUMBiological
Also called XIAFLEX, XIAPEX
Subdermal dose

Study groups in NCT01518907
Study group	Role	What they receive
AA4500 0.0029 mg in 1 mL	Experimental	Not described Receives: Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.0145 mg in 5 mL	Experimental	Not described Receives: Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.0145 mg in 1 mL	Experimental	Not described Receives: Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.0435 mg in 5 mL	Experimental	Not described Receives: Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.0435 mg in 1 mL	Experimental	Not described Receives: Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.116 mg in 5 mL	Experimental	Not described Receives: Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.116 mg in 1 mL	Experimental	Not described Receives: Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.232 mg in 5 mL	Experimental	Not described Receives: Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 at 0.232 in 1 mL	Experimental	Not described Receives: Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.464 mg in 5 mL	Experimental	Not described Receives: Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.464 mg in 1 mL	Experimental	Not described Receives: Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

What is being measured

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

Investigator global aesthetic improvement scale assessment of the target cellulite area
Measured: Day 90
Subject global aesthetic improvement scale assessment of the target cellulite area
Measured: Day 90
A responder analysis based on proportion of subjects with a ≥ 30% improvement from baseline in the absolute surface depth of the central dimple/depression based on 3D digital photography.
Measured: Day 90
Percent change from baseline in total absolute surface depth of the central dimple/depression based on 3D digital photography.
Measured: Day 90

Timeline

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

Jan 2012Feb 2013

First posted26 Jan 2012 (estimated)
Study startJan 2012
Primary completionDec 2012
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Edematous Fibrosclerotic PanniculopathyStudies 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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01518907
Sponsor's protocol ID: AUX-CC-830
Status last verified: Mar 2015
First submitted: 24 Jan 2012
Last updated: 19 Mar 2015
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b, Open-label, Dose-escalation Study of the Safety, Effectiveness, and Pharmacokinetics of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy Commonly Known as Cellulite
ClinicalTrials.gov ID: NCT01518907
Acronym / sponsor ID: AUX-CC-830
Conditions: Edematous Fibrosclerotic Panniculopathy, Cellulite
Keywords: cellulite, Xiaflex
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Dec 2012 (actual)
Study completion: Feb 2013 (actual)
First posted: 26 Jan 2012 (estimated)
Results: Not posted in the source record

Clinical summary

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

This study will evaluate the safety, effectiveness, pharmacokinetics, and immunogenicity of AA4500 at increasing doses and concentrations in the treatment of adult women with cellulite.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 11

Arm	Type	Receives
AA4500 0.0029 mg in 1 mL	Experimental	Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.0145 mg in 5 mL	Experimental	Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.0145 mg in 1 mL	Experimental	Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.0435 mg in 5 mL	Experimental	Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.0435 mg in 1 mL	Experimental	Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.116 mg in 5 mL	Experimental	Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.116 mg in 1 mL	Experimental	Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.232 mg in 5 mL	Experimental	Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 at 0.232 in 1 mL	Experimental	Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.464 mg in 5 mL	Experimental	Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
AA4500 0.464 mg in 1 mL	Experimental	Biological: COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

Who may qualify

Ages: 21 to 60 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (15 listed)

Be a female and be ≥ 21 years of age and ≤ 60 years of age
Have a skin type classification of I through V according to the Fitzpatrick scale
Have EFP within the posterolateral thigh(s) and/or buttock(s) for at least 12 months before the screening visit
Have a photonumeric cellulite severity scale (CSS) score of ≥ 7 representing moderate to severe cellulite severity within the right or left buttock or the right or left posterolateral thigh (selected quadrant)
Have an area of EFP within the selected quadrant that is at least 8 cm x 10 cm (ie, target EFP area) and is suitable for treatment:

Key exclusion criteria (32 listed)

Has any of the following conditions:
Has used any of the following for the treatment of EFP on the legs or buttock or intends to use any of the following at any time during the study:
Has a tattoo in the quadrant selected for treatment
Is presently nursing a baby or providing breast milk for a baby
Intends to become pregnant during 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
COLLAGENASE CLOSTRIDIUM HISTOLYTICUMAlso: XIAFLEX, XIAPEXSubdermal dose	Biological	AA4500 0.0029 mg in 1 mL, AA4500 0.0145 mg in 1 mL, AA4500 0.0145 mg in 5 mL, AA4500 0.0435 mg in 1 mL, AA4500 0.0435 mg in 5 mL, AA4500 0.116 mg in 1 mL, AA4500 0.116 mg in 5 mL, AA4500 0.232 mg in 5 mL, AA4500 0.464 mg in 1 mL, AA4500 0.464 mg in 5 mL, AA4500 at 0.232 in 1 mL

Primary outcome

Investigator global aesthetic improvement scale assessment of the target cellulite area
Time frame: Day 90
Subject global aesthetic improvement scale assessment of the target cellulite area
Time frame: Day 90
A responder analysis based on proportion of subjects with a ≥ 30% improvement from baseline in the absolute surface depth of the central dimple/depression based on 3D digital photography.
Time frame: Day 90
Percent change from baseline in total absolute surface depth of the central dimple/depression based on 3D digital photography.
Time frame: Day 90

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.

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.

Veronica Urdaneta, MD MPH study director

Endo USA Inc., a Keenova Therapeutics Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 inclusion and 32 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 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Investigator global aesthetic improvement scale assessment of the target cellulite area (time frame: Day 90). The study lists 4 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 NCT01518907.

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 19 Mar 2015.