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

NCT ID: NCT01688076

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2025-12-31

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.

Conditions

Forehead Rhytid Complex; Glabellar Rhytid Complex

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Botulinum Toxin A

Intervention Type: PROCEDURE

Forehead will be injected with Botox.

No muscle contractions

Patients will be asked to not perform muscle contractions following Botox injections.

Group Type: ACTIVE_COMPARATOR

Botulinum Toxin A

Intervention Type: PROCEDURE

Forehead will be injected with Botox.

Interventions

Botulinum Toxin A

Forehead will be injected with Botox.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Murad Alam

Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU56722

Identifier Type: -

Identifier Source: org_study_id