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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.

Eflornithine HCl 13.9% cream (Vaniqa) is a novel treatment for the management of unwanted facial hair in women. This paper reports the results of four modified open-label, within-subject vehicle-controlled studies evaluating the dermal safety of this topical treatment. In a repeated insult patch test (230 subjects), erythema with oedema occurred in 38.9% of subjects treated with eflornithine HCl 13.9% cream and 4.8% of subjects treated with vehicle cream. Challenge applications at previously untested sites following the three-week induction period produced noticeable erythema or greater on only four sites treated with eflornithine HCl 13.9% cream and one vehicle-treated site. The erythema at these sites subsided substantially within 24 hours. In a three-week cumulative irritation study (30 subjects), the mean irritation score for sites treated with eflornithine HCl 13.9% cream was 1.33, compared with 0.76 at vehicle-treated sites and 3.09 at positive-control (sodium lauryl sulphate-treated) sites (p < 0.001 between all three groups). In a phototoxicity study (25 subjects), irradiated sites showed either no reaction (40% of both sites treated with eflornithine HCl 13.9% cream and vehicle-treated sites), or mild erythema subsiding in all cases but one within 24 hours. No reaction was seen at non-irradiated sites. In a photocontact allergy study (30 subjects), challenge with eflornithine HCl 13.9% cream or its vehicle alone produced either no reaction or mild erythema subsiding within 24 hours at both irradiated and non-irradiated sites. No serious adverse events were reported during the studies, and the only adverse events considered related to treatment were pruritus (three subjects) and dry skin at test site (one subject). These results demonstrate that eflornithine HCl 13.9% cream does not have contact sensitising, photocontact allergic or phototoxic properties. It can cause irritation under exaggerated conditions of use. Eflornithine HCl 13.9% cream, therefore, has a favourable dermal safety profile appropriate for a topical treatment to be applied routinely.

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