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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 30, 2005 | ||||||||
| Last Updated Date | October 16, 2009 | ||||||||
| Start Date ICMJE | January 2010 | ||||||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Reduction and/or elimination of cellulite in the posterolateral thigh [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Reduction and/or elimination of cellulite in the posterolateral thigh | ||||||||
| Change History | Complete list of historical versions of study NCT00261144 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Collagenase in the Treatment of Cellulite | ||||||||
| Official Title ICMJE | Collagenase in the Treatment of Cellulite | ||||||||
| Brief Summary | The purpose of this study is to determine if collagenase injection will reduce or eliminate the appearance of cellulite of the thigh. |
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| Detailed Description | This is an open label study of collagenase injection therapy for reduction and/or elimination of cellulite of the posterolateral thighs. |
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| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Cellulite | ||||||||
| Intervention ICMJE | Drug: Collagenase | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | January 2011 | ||||||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00261144 | ||||||||
| Responsible Party | Principal Investigator, SUNY Stony Brook, NY | ||||||||
| Study ID Numbers ICMJE | Cell 101 | ||||||||
| Study Sponsor ICMJE | Stony Brook University | ||||||||
| Collaborators ICMJE | Biospecifics Technologies Corp. | ||||||||
| Investigators ICMJE |
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| Information Provided By | Stony Brook University | ||||||||
| Verification Date | October 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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