Vaniqa FDA data, 2000  Title: FDA submission
Authors: Manufacturer
Journal:
PMID:
Affiliated institution: Bristol-Meyers
Squibb/Gillette
Cited in: Prescription insert at
www.vaniqa.com
Two randomized double-blind studies involving 594 female patients
(393 treated with VANIQA, 201 with vehicle) treated twice daily
for up to 24 weeks evaluated the efficacy of VANIQA in the reduction
of unwanted facial hair in women. Women in the trial had a customary
frequency of removal of facial hair two or more times per week.
Physicians assessed the improvement or worsening from the baseline
condition (Physician's Global Assessment [PGA]), 48 hours after
shaving, of all treated areas. Statistically significant improvement
for VANIQA versus vehicle was seen in each of these studies for
“marked improvement” or greater response (24-week time
point; p•0.001). Marked improvement was seen consistently
at 8 weeks after initiation of treatment and continued throughout
the 24 weeks of treatment. Hair growth approached pretreatment
levels within 8 weeks of treatment withdrawal. Approximately 32%
of patients showed marked improvement or greater (protocol definition
of clinical success) after 24 weeks of treatment with VANIQA,
compared to 8% with the vehicle. Combined results of these two
trials through 24 weeks are presented below.
| PGA Outcome |
VANIQA |
Vehicle |
| Clear/almost clear |
5% |
0% |
| Marked improvement |
27% |
8% |
| Improved |
26% |
26% |
| No improvement/worse/missing |
42% |
66% |
Subgroup analyses appeared to suggest greater benefit for Whites
than non-Whites (37% vs. 22% success, respectively; p=0.017).
However, non-Whites, mostly Black subjects, did have significant
treatment benefit with 22% graded as success on VANIQA compared
to 5% on vehicle. About 12% of women in the clinical trials were
postmenopausal. Significant improvement in PGA outcome versus
vehicle was seen in postmenopausal women (38% compared to 0%,
p•0.001). VANIQA statistically significantly reduced how
bothered patients felt by their facial hair and by the time spent
removing, treating, or concealing facial hair. These patient-observable
differences were seen as early as 8 weeks after initiating treatment.
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hair removal
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