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

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

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

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

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

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

Relative effectiveness evaluated in 2 ways:

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

2. Prospectively - evaluation of outcomes after at least 4 months of treatment

Retrospective phase - inclusion

Females Prior use of only one of the hormonal

treatments for acne No prior use of oral isotretinoin

Retrospective phase - results

N= 91

No difference between groups:•Mean age•Duration of acne•Duration of treatment

Tricyclen 36

Alesse 11

Diane-35 44

Effectiveness ratingsPreparation N Effectiveness

rating1

Proportion rating2

Tricyclen 36 1.4 22%

Alesse 11 1.7 19%

Diane-35 44 2.0 42%

1. Patient responses converted numerically with higher numbers = greater effectiveness2. Proportion of patients rating treatment as moderate-extremely effective

Prospective phase Inclusion criteria

1. females;2. no history of oral isotretinoin use3. only one hormonal treatment prescribed at visit

1 or 2 4. no other hormone treatments within 2 months

of visit 1 5. if hormone started at visit 1, this was not

changed at visit 26. Visit 3 (6 month) data available7. Minimum compliance of 75%

Acne-QoL™Domain Item Field

Self perception

Feeling unattractive Feeling embarrassed Feeling self-conscious Dissatisfied with appearance Self-confidence (negatively affected)

Emotional Feeling upset Annoyed about time spent cleaning and treating faceConcern about not looking your best

Concern about acne medication not working fast enough Bothered by need to have medication and cover-up available

Social Concern about meeting new people

Concern about going out in public

Problems socializing Problems interacting with the opposite sex

Symptoms Bumps on your faceBumps full of pus on face

Scabbing from facial acne Concern about scarring from facial acne Oily facial skin

(with permission from Merck & Co.)

•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™

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

Patient rating treatment as moderate-extremely effective: 12/17 (71%)

Objective improvement (Leeds, IGA) 12/17 (71%)

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

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