Patient reported outcomes effectiveness of hormonal treatments for acne
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Patient reported outcomes: Effectiveness of hormonal treatments for acne. Jerry Tan MD, FRCP 1 Karen Y. Fung PhD 2 1 University of Western Ontario and 2 University of Windsor, Windsor, Ont. . Declarations. Conflict of interest: Study sponsored by Berlex, Roche, Stiefel, Dermik

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Patient reported outcomes effectiveness of hormonal treatments for acne

Patient reported outcomes:Effectiveness of hormonal treatments for acne

Jerry Tan MD, FRCP1

Karen Y. Fung PhD2

1University of Western Ontario and

2University of Windsor, Windsor, Ont.


Declarations
Declarations

  • Conflict of interest:

    • Study sponsored by Berlex, Roche, Stiefel, Dermik

  • Acknowledgements:

    • Canadian Acne Study Group: Richard Thomas, Yves Poulin, Aditya Gupta, Sheetal Sapra, Wayne Gulliver, Charles Lynde, Rolf Sebaldt


Background
Background

3 hormonal preparations currently indicated in Canada for treatment of acne:

  • Tri-Cyclen® (Ortho-McNeil)

  • Alesse® (Wyeth)

  • Diane-35® (Berlex)

    There are no clinical trials comparing their relative effectiveness


Objective
Objective

  • To determine the relative effectiveness of these 3 hormonal agents in treatment of acne

  • To evaluate the effect of hormonal treatment on acne-specific quality of life


Methods i
Methods I

Data from Canadian acne epidemiological survey (observational study )

  • New acne patients

  • Referred to 7 participating dermatologists

  • Clinical evaluations

    • IGA, Leeds score, Acne-QoL™

  • Treatment: usual clinical practice


Methods ii
Methods II

Relative effectiveness evaluated in 2 ways:

  • Retrospectively - patient responses to questions on effectiveness of previous hormonal therapy

  • Prospectively - evaluation of outcomes after at least 4 months of treatment


Retrospective phase inclusion
Retrospectivephase - inclusion

  • Females

  • Prior use of only one of the hormonal treatments for acne

  • No prior use of oral isotretinoin


Retrospective phase results
Retrospective phase - results

  • N= 91

  • No difference between groups:

    • Mean age

    • Duration of acne

    • Duration of treatment


Effectiveness ratings
Effectiveness ratings

  • 1. Patient responses converted numerically with higher numbers = greater effectiveness

  • Proportion of patients rating treatment as moderate-extremely effective


Prospective phase inclusion criteria
Prospective phase Inclusion criteria

  • females;

  • no history of oral isotretinoin use

  • only one hormonal treatment prescribed at visit 1 or 2

  • no other hormone treatments within 2 months of visit 1

  • if hormone started at visit 1, this was not changed at visit 2

  • Visit 3 (6 month) data available

  • Minimum compliance of 75%


Acne qol
Acne-QoL

(with permission from Merck & Co.)


Prospective phase results
Prospective phase - results

  • Prospective evaluation performed only for the Diane-35® cohort (N=17)

    • Insufficient sample sizes for Tricyclen® and Alesse® cohorts (N=1 each)


Results acne qol
Results: Acne-QoL

  • total score improvement of 19%

    (P = 0.017)

  • improvement in all 4 domains:

    • Self-perception

    • Symptoms (P < 0.05)

    • Emotional

    • Socialization (P = 0.24)


Results prospective analysis
Results: Prospective analysis

  • Patient rating treatment as moderate-extremely effective:

    • 12/17 (71%)

  • Objective improvement (Leeds, IGA)

    • 12/17 (71%)


Summary
Summary

Patients previously treated with one of the 3 hormonal preparations, ranked Diane-35 as the most effective.

Patients treated with Diane-35 demonstrated improvement in acne symptoms and acne-related emotional and self-perception domains


Study limitations
Study Limitations

  • Retrospective study

    • Recollection bias: comparator cohorts and sample size should minimize confounding

  • Prospective analysis

    • lack of a cohort comparator group

    • completion of Acne-QoL before medical encounter should reduce pre-bias of responses

    • results represent usual clinical practice of combining topical treatments with Diane-35


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