Treatment of Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection

• Sponsor: Northwestern University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01688076
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Duration (Months): 131
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Forehead Rhytid Complex; Glabellar Rhytid Complex	Procedure: Botulinum Toxin A	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Muscle contractions 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.	Procedure: Botulinum Toxin A; Forehead will be injected with Botox.
Active Comparator: No muscle contractions Patients will be asked to not perform muscle contractions following Botox injections.	Procedure: Botulinum Toxin A; Forehead will be injected with Botox.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Number of Participants with Adverse Events [13 months]

   Side effects and adverse events will be assessed

2. Level of Satisfaction [7 months]

   Patients will be asked to rate their satisfaction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Murad Alam, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
• ClinicalTrials.gov Identifier: NCT01688076
• Other Study ID Numbers: STU56722
• First Posted: Sep 19, 2012
• Last Update Posted: Jan 5, 2022
• Last Verified: Jan 1, 2022

• Additional relevant MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA

Study Results

No Results Posted as of Jan 5, 2022