Treatment of Forehead/Glabellar Rhytide Complex With Combination Botulinum Toxin A and Hyaluronic… (NCT01186835) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Forehead/Glabellar Rhytide Complex With Combination Botulinum Toxin A and Hyaluronic Acid Versus Botulinum Toxin A Injection Alone
United States20 participantsStarted 2011-02
Plain-language summary
The objective of this study is to determine whether the use of botulinum toxin (Dysport ®) in conjunction with a hyaluronic acid filler (Restylane®) will improve the appearance of wrinkles on the forehead and glabella (area between the eyebrows) better than botulinum toxin alone. These two products have been FDA approved to improve the appearance of facial wrinkles.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* In good health
* Is 18-65 years of age
* Has static and dynamic forehead/glabellar wrinkles
* Has willingness and the ability to understand and provide informed consent and communicate with the investigator
Exclusion Criteria:
* Pregnant or lactating
* Has received the following treatments in the forehead or glabellar region:
* botulinum toxin injections in the past 6 months
* ablative laser procedure in the past 6 months
* radiofrequency device treatment in the past 6 months
* ultrasound device treatment in the past 6 months
* medium to deep chemical peel in the past 6 months
* temporary soft tissue augmentation material in the past year
* semi-permanent soft tissue augmentation material in the past 2 years
* permanent soft tissue augmentation material
* Is planning to receive within the next 6 months, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) in the forehead or glabellar region.
* Is planning to use tretinoin or retinoic acid in the next 6 months
* Has an active infection in the forehead or glabellar region (excluding mild acne)
* Is allergic to cow's-milk protein
* Is allergic to albumin
* Taking aminoglycoside
* Has prior history of nodule formation or hypersensitivity reactions to lidocaine or hyaluronic acid derivatives
* Is currently using anticoagul…