Treatment of Forehead/Glabellar Rhytide Complex With Combination Botulinum Toxin A and Hyaluronic Acid Versus Botulinum Toxin A Injection Alone
|ClinicalTrials.gov Identifier: NCT01186835|
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : May 23, 2014
|Condition or disease||Intervention/treatment|
|Forehead/Glabellar Rhytid Complexes||Procedure: Combination Botulinum Toxin A and Hyaluronic Acid Procedure: Botulinum Toxin A|
|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|
|Primary Completion Date :||June 2011|
|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.
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|