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

NCT01688076 | Active Not Recruiting Phase 4

• 1 other identifier: STU56722
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Forehead Rhytid Complex; Glabellar Rhytid Complex

Outcome Measures

Primary Outcomes (1)

• Measurement of Forehead Wrinkles with Honeck Four Point Rating Scale

  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.

  13 months

Secondary Outcomes (2)

• Number of Participants with Adverse Events

  13 months

• Level of Satisfaction

  7 months

Study Arms (2)

Muscle contractions

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.

Procedure: Botulinum Toxin A

No muscle contractions

ACTIVE COMPARATOR

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

Procedure: Botulinum Toxin A

Interventions

Botulinum Toxin A PROCEDURE

Forehead will be injected with Botox.

Muscle contractions; No muscle contractions

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: September 19, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

US (1)