A Clinical Study Evaluaing the Efficacy, Safety, and Patient Satisfaction of Injectable Hylaronic Acid With 0.3% Lidocain Hydrochloride, Prevelle Silk, for Superficial, Vertical Perioral Lines and Superficial, Horizontal, Lateral Canthal Lines
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Goldman, Butterwick, Fitzpatrick and Groff.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Goldman, Butterwick, Fitzpatrick and Groff
Collaborator:
Mentor Worldwide, LLC
Information provided by:
Goldman, Butterwick, Fitzpatrick and Groff
ClinicalTrials.gov Identifier:
NCT01267149
First received: December 23, 2010
Last updated: December 27, 2010
Last verified: December 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 23, 2010 | ||||||||
| Last Updated Date | December 27, 2010 | ||||||||
| Start Date ICMJE | August 2010 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01267149 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Clinical Study Evaluaing the Efficacy, Safety, and Patient Satisfaction of Injectable Hylaronic Acid With 0.3% Lidocain Hydrochloride, Prevelle Silk, for Superficial, Vertical Perioral Lines and Superficial, Horizontal, Lateral Canthal Lines | ||||||||
| Official Title ICMJE | Phase 4 Study - A Clinical Study Evaluaing the Efficacy, Safety, and Patient Satisfaction of Injectable Hylaronic Acid With 0.3% Lidocain Hydrochloride, Prevelle Silk, for Superficial, Vertical Perioral Lines and Superficial, Horizontal, Lateral Canthal Lines | ||||||||
| Brief Summary | Statistical Hypotheses The Null Hypothesis: There is no difference in the reduction of lines in the treated areas as compared to baseline. Alternative Hypothesis: There is a difference in the reduction of lines in the treated areas as compared to baseline. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Not Provided | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Cosmetic Dermatology Practice Patients |
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| Condition ICMJE | Wrinkles | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 13 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
A. moderate to severe superficial, vertical perioral and horizontal canthus lines
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 35 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01267149 | ||||||||
| Other Study ID Numbers ICMJE | PRV-2010 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Mitchell Goldman MD, Goldman, Butterwick, Fitzpatrick and Groff | ||||||||
| Study Sponsor ICMJE | Goldman, Butterwick, Fitzpatrick and Groff | ||||||||
| Collaborators ICMJE | Mentor Worldwide, LLC | ||||||||
| Investigators ICMJE |
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| Information Provided By | Goldman, Butterwick, Fitzpatrick and Groff | ||||||||
| Verification Date | December 2010 | ||||||||
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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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