Phase 4 Completed N=50 Treatment

Botox Cosmetic and the Young Patient With Glabellar Furrows

Glabellar Furrows

Source: ClinicalTrials.gov NCT00856999 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcomePrimary: Reduction of the Facial Wrinkle Scale — 1.86; 2.10 units on a scale — p=<.001

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Reduction of the Facial Wrinkle Scale	1.86; 2.10	<.001 sig
PRIMARY Patient Assessed Frown-line Improvement	7; 24; 69	<.0004 sig

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00856999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.