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					Abstract No: 83
  TREATMENT OF ACNE VULGARIS IN WOMEN: CLINICAL
      EFFICACY OF A LOW-DOSE, 'ESTROPHASIC' ORAL
   CONTRACEPTIVE (OC) COMPRISING NORETHINDRONE
         ACETATE (NA) AND ETHINYL ESTRADIOL (EE)
                           1
                               J.K. Jain, 2U. Azam
 1
     LAC and USC Medical Center and 2Pfizer Pharmaceuticals Group, USA

Objective To assess the clinical efficacy of Estrostep, a low-dose OC
comprising phased EE (20, 30 and 35mcg on days 1-5, 6-12 and 13-21,
respectively, of a 28-day treatment cycle) in combination with NA 1mg
daily, in the treatment of moderate acne vulgaris in women.       Methods
Two multicenter, randomized studies of Estrostep versus placebo in 593
women with moderate acne vulgaris. (1) Efficacy assessments were: change
from baseline in facial acne lesion counts; physician-reported Facial Acne
Global Assessment (FAGA); and patients' own assessment of treatment
efficacy using an exit questionnaire. The FAGA evaluates the qualitative
status of acne using a well-defined, 7-category rating scale.       Results
Estrostep significantly improved acne symptoms versus placebo according
to all efficacy measures. Significantly greater reductions from baseline in
mean counts for all lesion types were observed among Estrostep than
placebo patients (total lesions, p<0.001; inflammatory lesions, p=0.0014;
comedones, p=0.0003). The percentages of Estrostep versus placebo patients
with FAGA ratings at study exit of absent or minimal were 17% versus 8%
(p=0.0008) and of absent, minimal or mild were 44% versus 30%
(p=0.0004), respectively. Eighty four percent of Estrostep versus 65% of
placebo patients (p<0.001) classified their acne symptoms at study exit as
somewhat or much improved from baseline.                Conclusions The
combination of FAGA and lesion counts provides a thorough and rigorous
evaluation of treatment outcome. Using these measures, Estrostep
significantly improved moderate acne vulgaris in women. Reference 1.
        Maloney JM et al. Clin J Women's Health 2001;1:123-31

				
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