Overview

This trial is active, not recruiting.

Conditions forehead rhytid complex, glabellar rhytid complex
Treatment botulinum toxin a
Sponsor Northwestern University
Start date January 2012
End date December 2016
Trial size 25 participants
Trial identifier NCT01688076, STU56722

Summary

This cross-over design study will evaluate the onset of action, efficacy, and duration of botulinum toxin A treatment on forehead/glabellar rhytid complexes with and without subsequent muscle contraction.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Under supervision by study personnel, subjects be asked to make active muscle contractions for one hour after Botox injections. Subjects will return for follow-up visits.
botulinum toxin a
Forehead will be injected with Botox.
(Active Comparator)
Patients will be asked to not perform muscle contractions following Botox injections.
botulinum toxin a
Forehead will be injected with Botox.

Primary Outcomes

Measure
Measurement of Forehead Wrinkles with Honeck Four Point Rating Scale
time frame: 13 months

Secondary Outcomes

Measure
Number of Participants with Adverse Events
time frame: 13 months
Level of Satisfaction
time frame: 7 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - In good health - Is 18-65 years of age - Has static and dynamic forehead/glabellar wrinkles - Has decided to receive Botox® treatment for their forehead/glabellar wrinkles - Has the willingness and ability to understand and provide informed consent and communicate with the investigator - Is willing to return for follow-up visits 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 year, 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 year - 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 - Is currently using anticoagulation therapy - Has a history of bleeding disorders - Is unable to understand the protocol or to give informed consent - Is unable to return for follow-up visits - Has a mental illness

Additional Information

Official title Treatment of Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection: Impact of Muscle Contraction on Onset of Action, Efficacy, and Duration of Treatment
Principal investigator Murad Alam, MD
Description In this cross-over design study, the investigators will evaluate whether active muscle contraction following Botox® injection of the forehead/glabellar rhytid complex will impact the onset of action, efficacy, and duration of Botox® treatment.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Northwestern University.