CellulitePhase 2NCT00261144
Collagenase in the Treatment of Cellulite
A Phase 2 study testing Collagenase and Biological in people with Cellulite, run by Stony Brook University at 1 site in United States.
Trial summary
The purpose of this study is to determine if collagenase injection will reduce or eliminate the appearance of cellulite of the thigh. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cellulite
- What is being tested?
- Collagenase and Biological
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Mar 2014
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 10 x 10 cm area of cellulite of the posterolateral thigh(s)
Who cannot join
- any chronic, serious or uncontrolled medical condition
- inability to conform to study visits (12-15 per year)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dept. Orthopaedics, SUNY Stony Brook
Stony Brook, New York, 11794
Marie A Badalamente, PhD, 631-444-2215, Marie.Badalamente@stonybrookmedicine.edu
Gail Trocchio, 631 444 2215, Gail.Trocchio@stonybrookmedicine.edu
About this study
The purpose of this study is to determine if collagenase injection will reduce or eliminate the appearance of cellulite of the thigh.
Read the detailed description
This is an open label study of collagenase injection therapy for reduction and/or elimination of cellulite of the posterolateral thighs.
- Conditions
- Cellulite
- Being tested
- Collagenase, Biological
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CollagenaseDrug
One 0.58mg injection every two weeks for six weeks (total three 0.58mg injections)
BiologicalBiological
Also called Collagenase
Collagenase injection
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction and/or elimination of cellulite in the posterolateral thigh
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CelluliteStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie A. Badalamente, Stony Brook University
- Investigators
- Marie A Badalamente, PhD, Principal investigator, Dept. Orthopaedics, SUNY@Stony Brook, NY 11794Alexander B Dagum, MD, Principal investigator, Dept. Surgery, SUNY@Stony Brook, NY 11794
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261144
- Sponsor's protocol ID
- Cell 101
- Status last verified
- Dec 2012
- First submitted
- 30 Nov 2005
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagenase in the Treatment of Cellulite
- ClinicalTrials.gov ID
- NCT00261144
- Acronym / sponsor ID
- Cell 101
- Conditions
- Cellulite
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 2 Dec 2005 (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.
The purpose of this study is to determine if collagenase injection will reduce or eliminate the appearance of cellulite of the thigh.
Detailed description
This is an open label study of collagenase injection therapy for reduction and/or elimination of cellulite of the posterolateral thighs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 10 x 10 cm area of cellulite of the posterolateral thigh(s)
Key exclusion criteria (2 listed)
- any chronic, serious or uncontrolled medical condition
- inability to conform to study visits (12-15 per year)
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 |
|---|---|---|
| CollagenaseOne 0.58mg injection every two weeks for six weeks (total three 0.58mg injections) | Drug | – |
| BiologicalAlso: CollagenaseCollagenase injection | Biological | – |
Primary outcome
Reduction and/or elimination of cellulite in the posterolateral thigh
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
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Pilot Study of Naringenin Beta Carotene Cream for Local Fat Reduction (SCULPT)
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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.
Marie A Badalamente, PhD principal investigator
Dept. Orthopaedics, SUNY@Stony Brook, NY 11794
Alexander B Dagum, MD principal investigator
Dept. Surgery, SUNY@Stony Brook, NY 11794
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Collagenase and Biological in people with Cellulite, run by Stony Brook University at 1 site in United States.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Dec 2012. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie A Badalamente, PhD (631 444 2215, Marie.Badalamente@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction and/or elimination of cellulite in the posterolateral thigh (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2012.