Botox Cosmetic and the Young Patient With Glabellar Furrows

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 4

Conditions: Glabellar Furrows

Treatments: Drug: Botox

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00856999

AGNR-08-0093

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Botox

Experimental group

Description:

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

Treatment:

Drug: Botox