The effect of eflornithine 13.9% cream on the bother and discomfort due to hirsutism.
Although unwanted facial hair often leads to anxiety and avoidance of social situations, evaluation of treatment outcomes in clinical trials has relied largely on measures external to the patient such as the extent of hair growth or an expert physician's assessment, neglecting to include patient reported outcomes (PRO). To assess the level of bother caused by a dermatological condition (hirsutism) and changes brought on by treatment, the instrument ESTEEM was developed by expanding the Bother Assessment in Skin Conditions (BASC) scale to six questions to cover the discomfort felt in four social situations and bother due to removing facial hair. Each question elicits responses on a visual analog scale. Women participating in two randomized clinical trials evaluated a new treatment (eflornithine 13.9% cream). Analyses examined the level of bother at each visit, the changes with treatment, the correlations with the Physician's Global Assessment, and the effect size. Hirsutism bothers patients considerably. The mean for overall bother was 89% and the mean discomfort in social situations exceeded 80% in nearly all cases. Treatment led to significant reductions in bother on all six items with effect sizes ranging from 0.46 to 1.62. Eflornithine is an effective treatment for unwanted facial hair in women, as reported by the patients. ESTEEM addresses the specific concerns of women with hirsutism.
Jackson
Joseph
J
Bristol Myers-Squibb Pharmaceutical Research Institute, Princeton, New Jersey, USA.
Caro
J Jaime
JJ
Caro
Graciela
G
Garfield
Frances
F
Huber
Ferdinand
F
Zhou
Wenjiong
W
Lin
Chen-Sheng
CS
Shander
Douglas
D
Schrode
Kathy
K
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D000518:Eflornithine / Q000627:therapeutic use*; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D005145:Face; D005260:Female; D006197:Hair / Q000254:growth & development; D006628:Hirsutism / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D008875:Middle Aged; D015999:Multivariate Analysis; D065108:Ornithine Decarboxylase Inhibitors; D011788:Quality of Life; D016896:Treatment Outcome