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Thursday, november 3, 2005
PATIENT REPORTED OUTCOMES OF HORMONAL TREATMENTS FOR ACNE
There are no comparative clinical trials on the comparative efficacy of the three hormonal preparations currently indicated
in Canada for treatment of acne; namely Tri-Cyclen® (Ortho-
McNeil), Alesse® (Wyeth), and Diane-35® (Berlex).
Comparative effectiveness in acne for these 3 hormonal agents was sought from the Canadian acne epidemiological survey.
Relative effectiveness was evaluated in 2 ways:
• retrospective patient responses to questions on
effectiveness of previous hormonal therapy, and
• prospective evaluation of outcomes (IGA, Leeds score,
Acne-QoL) for patients prescribed these hormones for a minimum of 4 to maximum of 6 months.
Mean effectiveness scores based on retrospective patient
responses were: 1.36 for Tricyclen®, 1.73 for Alesse® and 2.0
for Diane 35®. Proportions of patients rating these treatments as moderate-extremely effective were 22% for Tricyclen®, 19%
for Alesse® and 42% for Diane 35® (P = 0.044). Prospective
evaluation was performed only for the Diane-35® cohort (N=
17) as insufficient sample sizes were obtained for Tricyclen®
and Alesse® cohorts (N=1 each). Objective improvement in
acne was observed in 12/17 (70.6%) patients. Overall improvement in Acne-QoL total score was 19% (P = 0.017)
with significant subscale improvement in 3 of 4 domains (self-
perception, symptoms, role-emotional). Seventy-one percent of
patients (12 out of 17) rated Diane 35® as moderately-
extremely effective in treatment of acne after 4-6 months of
Female acne patients previously treated with one of the 3
hormonal preparations indicated in Canada for treatment of
acne ranked Diane-35® more highly for effectiveness than
Tricyclen® or Alesse®. Patients were more likely to rate
previous treatment with Diane-35® as moderately-extremely effective compared to these other hormonal preparations. After
up to 6 months treatment with Diane-35®, objective
improvement in at least one acne-affected region was observed
in 71% of patients. The majority of these patients (71%) rated
Diane-35® as moderately-extremely effective in treatment of
acne. Diane-35® was also associated with improvement in acne-specific quality of life (Acne-QoL).
• Retrospective recall for rating effectiveness – however,
comparator cohorts should minimize confounding.
• The lack of a cohort comparator group in the
prospective analysis increases the risk for potential
• The combination with topical acne agents and oral
antibiotics may confound effectiveness outcome
determination of Diane-35® alone but is consistent with
usual clinical practice and combination therapy.
The Canadian Acne Epidemiological Survey is partially funded
by educational grants from Berlex, Roche, Dermik and Stiefel.
1 Dept. of Medicine, University of Western Ontario, Windsor,
2 Dept. of Mathematics & Statistics, University of Windsor,
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