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Botox Cosmetic and the Young Patient With Glabellar Furrows

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00856999
First received: March 4, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Glabellar Furrows
Drug: Botox
Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Botox Cosmetic and the Young Patient With Glabellar Furrows

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Arms Assigned Interventions
Experimental: Botox
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
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

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856999

Sponsors and Collaborators
Oregon Health and Science University
Allergan
Investigators
Principal Investigator: Roger Dailey, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Roger Dailey, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00856999     History of Changes
Other Study ID Numbers: AGNR-08-0093
Study First Received: March 4, 2009
Last Updated: March 4, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Glabellar lines of moderate severity at maximum frown

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014