Treatment of Forehead/Glabellar Rhytide Complex With Combination Botulinum Toxin A and Hyaluronic Acid Versus Botulinum Toxin A Injection Alone
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|ClinicalTrials.gov Identifier: NCT01186835|
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : May 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Forehead/Glabellar Rhytid Complexes||Procedure: Combination Botulinum Toxin A and Hyaluronic Acid Procedure: Botulinum Toxin A||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Treatment of Forehead/Glabellar Rhytide Complex With Combination Botulinum Toxin A and Hyaluronic Acid Versus Botulinum Toxin A Injection Alone: A Split-face, Rater-blinded Randomized Control Trial|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Experimental: Combination Botulinum Toxin A and Hyaluronic Acid
One side of face treated with the combination of Botulinum Toxin A and Hyaluronic Acid injections.
Procedure: Combination Botulinum Toxin A and Hyaluronic Acid
One side of subject's face will randomly be assigned combination treatment.
Active Comparator: Botulinum Toxin A alone
Other side of face treated with =Botulinum Toxin A injection alone.
Procedure: Botulinum Toxin A
Other side of subjects face with receive Botulinum Toxin A treatment alone.
- Measure: [ Time Frame: 1 year ]Two blinded dermatologists will rate each photograph of each subject at baseline, week 2, month 3, and month 6. The raters will provide a glabellar wrinkle score and a forehead wrinkle score for each photograph. The raters will not know what treatments the subjects received or at what point in time the photographs were taken.
- Measure: Percent Improvement [ Time Frame: 1 year ]
- Two blinded dermatologists will also rate the percent improvement between the before and after photographs (Appendix III).
- A live blinded dermatologist will determine which side looks better at week 0, week 2, month 3, and month 6.
- A subject self-evaluation will be administered at week 2, month 3, and month 6.
- A subject satisfaction questionnaire will be administered at month 6.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186835
|United States, Illinois|
|Northwestern University Dermatology|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Murad Alam, MD||Northwestern University|