Botox Cosmetic and the Young Patient With Glabellar Furrows

NCT00856999 | Completed Phase 4 Results

• 1 other identifier: AGNR-08-0093
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to see if consistent treatment with Botox will lead to longer lasting effects. Botox is an injectable liquid that is approved by the U.S. Food and Drug Administration to reduce wrinkles on the forehead in the area between the eyebrows. In this study a different dosing schedule of Botox injections will be used to see if the effects of the Botox treatment last longer than the effects of the standard injection regimen.

Conditions

Glabellar Furrows

Keywords

Glabellar lines of moderate severity at maximum frown

Outcome Measures

Primary Outcomes (2)

• Reduction of the Facial Wrinkle Scale

  Four-point validated facial wrinkle scale (FWS) Minimum score = 0 (no wrinkles) Maximum score = 3 (deep wrinkles) Baseline to 20 months is the active injection phase 20 months to 26 months is the follow-up phase

  26 months

• Patient Assessed Frown-line Improvement

  Four-point satisfaction scale Neutral = 0 (minimum score) Somewhat satisfied = 1 Definitely satisfied = 2 Greatly satisfied = 3 Couldn't be more satisfied = 4 (maximum score) Baseline to 20 months is the active injection phase 20 months to 26 months is the follow-up phase

  20 months

Study Arms (1)

Botox

EXPERIMENTAL

Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups

Drug: Botox

Interventions

Botox DRUG

Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups

Botox

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Fitzpatrick Skin Types I-III
• Between 30 and 50 years of age
• At least moderate severity at maximum frown

You may not qualify if:

• Prior botulinum toxin treatment
• Any disorder (such as myasthenia gravis, Eaton-Lambert syndrome) or agent (such as aminoglycoside antibiotics) that might interfere with neuromuscular function
• Any other condition or situation that might put the subject at significant risk, confound the study results (such as significant pre-existing brow or eyelid ptosis)
• Allergy or sensitivity to any study component
• Participation in another clinical study within 30 days of the study start date
• Are planning other facial cosmetic procedures during the study period, or are pregnant, breastfeeding, or planning a pregnancy during the study.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Allergan: collaborator

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

Results Point of Contact

• Title: Roger Dailey, MD, FACS
• Organization: Oregon Health & Sciences University

daileyr@ohsu.edu

503-494-3020

Study Officials

• Roger Dailey, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2009
• First Posted: March 6, 2009
• Study Start: February 8, 2005
• Primary Completion: November 17, 2010
• Study Completion: November 17, 2010
• Last Updated: July 23, 2019
• Results First Posted: July 23, 2019

Record last verified: 2019-07