Jg. Hickman et al., Human dermal safety studies with eflornithine HCl 13.9% cream (Vaniqa (TM)), a novel treatment for excessive facial hair, CURR MED R, 16(4), 2001, pp. 235-244
Eflornithine HCl 13.9% cream (Vaniqa(TM)) is a novel treatmelztfor the mana
gement of unwanted facial hair in women. This paper reports the results of
four modified open-label, within-subject vehicle-controlled studies evaluat
ing the dermal safety of this topical treatment. In a repeated insult patch
test (230 subjects), erythema with oedema occurred in 38.9% of subjects tr
eated with eflornithine HCl 13.9% cream and 4.8% of subjects treated with v
ehicle 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. Ivr a three-week cumulative irritation study (230 subjects), the me
an irritation score for sites treated with eflornithine HCl 13.9% cream was
1.33, compared with 0.76 at vehicle-treated sires and 3.09 at positive-con
trol (sodium lauryl sulphate-treated) sites (p < 0.001 between all three gr
oups). In a phototoxicity study (25 subjects), irradiated sites showed eith
er 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 on
e within 24 hours. No reaction was seen at non-irradiated sites. In a photo
contact allergy study (30 subjects), challenge with eflornithine HCl 13.9%
cream or its vehicle alone produced either Mo reaction or mild erythema sub
siding within 24 hours at both irradiated and nonirradiated sites. No serio
us adverse events were reported during the studies, and the only adverse ev
ents considered related to treatment were pruritus (three subjects) and dry
skin at test site tone subject. These results demonstrate that eflornithin
e HCl 13.9 % cream does not have contact sensitising, photocontact allergic
or phototoxic properties. It can cause irritation under exaggerated condit
ions of use. Eflornithine HCl 13.9% cream, therefore, has a favourable derm
al safety profile appropriate for a topical treatment to be applied routine
ly.