Sculptra, , is a proprietary formulation of poly-L-lactic acid (PLLA) that is an

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

-approved

dermal The dermis or corium is a layer of skin between the epidermis (with which it makes up the cutis) and subcutaneous tissues, that primarily consists of dense irregular connective tissue and cushions the body from stress and strain. It is divided in ...

filler manufactured by Dermik Laboratories, which conducts the American business of Aventis Dermatology, the global dermatology unit of

Aventis Sanofi S.A. is a French multinational pharmaceutical and healthcare company headquartered in Paris, France. Originally, the corporation was established in 1973 and merged with Synthélabo in 1999 to form Sanofi-Synthélabo. In 2004, Sanofi-Syn ...

(of

Sanofi-Aventis Sanofi S.A. is a French multinational pharmaceutical and healthcare company headquartered in Paris, France. Originally, the corporation was established in 1973 and merged with Synthélabo in 1999 to form Sanofi-Synthélabo. In 2004, Sanofi-Syn ...

). PLLA was approved by the FDA on August 3, 2004, for the treatment of facial

fat In nutrition science, nutrition, biology, and chemistry, fat usually means any ester of fatty acids, or a mixture of such chemical compound, compounds, most commonly those that occur in living beings or in food. The term often refers spec ...

loss (also called facial

lipoatrophy Lipoatrophy is the term describing the localized loss of fat tissue. This may occur as a result of subcutaneous injections of insulin in the treatment of diabetes, from the use of human growth hormone or from subcutaneous injections of copaxone use ...

). According to documents from the US Food and Drug Administration, the FDA initially approved the drug on the basis of small studies conducted on HIV patients, specifically “for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with

human immunodeficiency virus The human immunodeficiency viruses (HIV) are two species of ''Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause AIDS, acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the ...

(HIV). Facial lipoatrophy is a condition in which people lose fat in their faces, especially in their cheeks and around their eyes and temples. People with

HIV The human immunodeficiency viruses (HIV) are two species of ''Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune ...

who take anti-HIV drugs may develop lipoatrophy. Sculptra was subsequently approved by the FDA for use with non-HIV patients with wrinkles, despite substantial complications reported to the FDA. *

Lipodystrophy Lipodystrophy syndromes are a group of genetic or acquired disorders in which the body is unable to produce and maintain healthy fat tissue. The medical condition is characterized by abnormal or degenerative conditions of the body's adipose tissue. ...

After the injection, it will take around 1 to 1.5 months to grow natural collagen. Bruising and swelling may occur post injection, which will go down within a week. After the injection, patients are directed to massage the treatment area in order to maintain smooth, level and evenly distributed results and prevent granuloma formation.

Sculptra used in Cosmetic Medicine

Today, Sculptra is used "off label" for other aesthetic enhancements, such as a non-surgical butt lift, alongside a wide range of anatomical regions of the body for overall rejuvenatory effects.

References

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