The following 3-D images represent baseline and Day 30 images of target dimples from two subjects who participated in the study. Red color identifies the deepest areas within the target dimple, while blue color shows the areas with shallower depth closest to the normal skin surface. Following a single injection of XIAFLEX, subject 1227 demonstrated a 30.6% improvement in target dimple volume at Day 30 and subject 1057 demonstrated a 42.1% improvement in target dimple volume at Day 30. These results are not representative of all subjects, but help demonstrate the extent of visible improvement across patients.
"Thirty-day data from our phase Ib cellulite clinical trial represents another important development milestone for Auxilium as we advance a fourth potential indication of CCH in development, further diversifying XIAFLEX's growing pipeline," explained
, Chief Executive Officer and President of Auxilium. "We believe cellulite represents a significantly undertreated condition and that innovative approaches such as CCH may, if approved, one day be a viable solution for treatment."
Cellulite, also known medically as edematous fibrosclerotic panniculopathy or EFP, describes a pathologic condition, in which lobules of subcutaneous adipose tissue extend into the dermal layer. Cellulite can involve the loss of elasticity or shrinking of collagen cords, called septae, that attach the skin to lower layers of muscle. When fat in cellulite prone areas swells and expands, the septae tether the skin, which causes surface dimpling characteristic of cellulite. These changes can visibly affect the shape of the epidermis and resemble an orange peel-like dimpling of the skin.
CCH treatment is intended to target and lyse, or break, those collagen tethers with the goal of releasing the skin dimpling and potentially resulting in smoothing of the skin.
In the normal subcutaneous fat layer directly under the skin, there are both perpendicular columnar and net-like fibrous connective tissue called septae. These fibrous septae, made of types I and III collagen, connect the epidermis to the dermis and create a network of compartmentalized adipose deposits. Women tend to have a higher proportion of columnar septae that are perpendicular to the epidermis, while men tend to have more of the net-like system. In cellulite, the subcutaneous fat cells swell and push upwards.
As a result, the skin between the septae is pushed up and the perpendicular septae act as an anchor to pull the epidermis downwards and form the classic cellulite dimple. The surrounding adipose tissue forms small bulges under the epidermis around the dimple that can give skin a "cottage cheese" texture
Cellulite occurs mainly on the buttocks, lower limbs, and abdomen and has been reported to occur in 85-98% of post-pubertal females and rarely in men. The condition is believed to be prevalent in women of all races.
Cellulite is different from generalized obesity. The fat cells found in generalized obesity are not limited to the pelvis, thighs, and abdomen. Further, the fat cells found in cellulite have different physiologic and biochemical property than fat tissue located elsewhere.
There is no definitive medical explanation for the presentation and prevalence of cellulite and, despite multiple types of therapeutic approaches for the attempted treatment of cellulite, there are no approved medical treatments and little scientific evidence that any current treatments are beneficial.