Forehead Rhytid Complex, Glabellar Rhytid Complex
Conditions
Brief 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.
Detailed 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.
Interventions
PROCEDUREBotulinum Toxin A
Forehead will be injected with Botox.
Sponsors
Northwestern University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Forehead Wrinkles with Honeck Four Point Rating Scale | 13 months | A single dermatologist will rate each photograph of the subject's forehead/glabellar rhytid complex at baseline, 1 day, 2 days, 3 days, 4 days, 7 days, 2 weeks, 7 months and 1 day, 7 months and 2 days, 7 months and 3 days, 7 months and 4 days, 7 months and 7 days, and 7 months and 2 weeks. A glabellar wrinkle score and a forehead wrinkle score will be assigned to each photograph. The dermatologist will not know at what point in time the photographs were taken. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events | 13 months | Side effects and adverse events will be assessed |
| Level of Satisfaction | 7 months | Patients will be asked to rate their satisfaction |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMurad Alam, MD
Northwestern University
Outcome results
None listed