Safety Data Supports Use of Fillers in Skin of Color Patients

ORLANDO, Fla. – Growing numbers of patients with deeper skin tones are seeking cosmetic procedures involving injectable fillers.

“Many women of color do not have fine lines and wrinkles; they have loss of volume of the skin with

descent of the malar fat pads, prominence of the nasolabial folds, and prominence of the tear troughs, so those are the very areas that are appropriate for injections in women with skin of color, and men as well,” said Dr. Susan Taylor at the Orlando Dermatology Aesthetic and Clinical Conference.

Dr. Taylor, who helped to establish the Skin of Color Center at St. Luke’s–Roosevelt Hospital Center (N.Y.), is now in private practice in Philadelphia. She reviewed the characteristics of aging in patients with skin of color and evidence for the safe use of fillers in these patients.

Patients with skin of color often appear about 10 years younger than white patients of the same age, Dr. Taylor noted. As patients with skin of color age, they tend to have fewer fine and deep rhytids than white patients. But patients with deeper skin tones in their 40s and 50s do experience gravity-dependent changes and volume loss, as well as skeletal changes and soft tissue changes. Thus, these transformations lend themselves to treatment with injectable fillers.

“The options for your skin of color patients are the same options that you have for Caucasian patients,” Dr. Taylor said.

But is it just as safe for persons of color as it is for patients with fair skin? “We know that keloidal scarring develops 3-18 times as often in African American patients as in Caucasian patients,” said Dr. Taylor.

Potential adverse events from soft tissue fillers in patients with Fitzpatrick skin types IV, V, and VI could include postinflammatory hyperpigmentation, postinflammatory hypopigmentation, keloidal scarring, and hypertrophic scarring.

The Food and Drug Administration has conducted postapproval safety studies in Fitzpatrick skin types IV (brown), V (dark brown), and VI (deepest brown to black) for nine dermal fillers, including Restylane, Perlane, and Sculptra, Dr. Taylor said.

Data from three postapproval studies of three fillers each showed that none of the patients with skin of color had hypersensitivity reactions or developed keloids after one or two injections of any of the fillers. Patients in the studies were followed for up to 6 months, approximately.

Overall, 20 (6%) of the 369 patients across the studies developed hyperpigmentation, and 1 developed hypopigmentation, Dr. Taylor said.

“The pigmentation changes were very subtle,” she said.

Changes in pigmentation after injecting fillers in skin or color patients may be due to injection techniques, the use of concomitant anesthesia, or the specific product, Dr. Taylor said.

She advised physicians to look carefully at a patient’s skin prior to injecting any filler to document any pigmentation that was already present to help determine sensitivity and guide their injections techniques accordingly.

There were limitations to the postapproval studies, including the lack of controls and relatively short-term follow-up, and the need for more data.

“But what we can say now is that it’s very important that you warn your patients about the possibility of postinflammatory hyperpigmentation in particular, although hypopigmentation can occur,” Dr. Taylor said. Inform patients that there is a theoretical risk of keloidal scarring, but there have been no reports of keloids in the literature, she added.

To reduce the risk of hyperpigmentation, try a linear threading technique or injecting a bit more deeply to reduce the risk of hyperpigmentation, and note any pigmentation changes over a long-term follow-up period, she said.

Dr. Taylor has served as an investigator, speaker, and/or advisory board member for Allergan, Bioform, Genzyme, Johnson & Johnson, Medicis, Mentor, and Merz.

_{Image above is of Dr. Susan Taylor/Photo Credit: Heidi Splete}

ORLANDO, Fla. – Growing numbers of patients with deeper skin tones are seeking cosmetic procedures involving injectable fillers.

“Many women of color do not have fine lines and wrinkles; they have loss of volume of the skin with

descent of the malar fat pads, prominence of the nasolabial folds, and prominence of the tear troughs, so those are the very areas that are appropriate for injections in women with skin of color, and men as well,” said Dr. Susan Taylor at the Orlando Dermatology Aesthetic and Clinical Conference.

Dr. Taylor, who helped to establish the Skin of Color Center at St. Luke’s–Roosevelt Hospital Center (N.Y.), is now in private practice in Philadelphia. She reviewed the characteristics of aging in patients with skin of color and evidence for the safe use of fillers in these patients.

Patients with skin of color often appear about 10 years younger than white patients of the same age, Dr. Taylor noted. As patients with skin of color age, they tend to have fewer fine and deep rhytids than white patients. But patients with deeper skin tones in their 40s and 50s do experience gravity-dependent changes and volume loss, as well as skeletal changes and soft tissue changes. Thus, these transformations lend themselves to treatment with injectable fillers.

“The options for your skin of color patients are the same options that you have for Caucasian patients,” Dr. Taylor said.

But is it just as safe for persons of color as it is for patients with fair skin? “We know that keloidal scarring develops 3-18 times as often in African American patients as in Caucasian patients,” said Dr. Taylor.

Potential adverse events from soft tissue fillers in patients with Fitzpatrick skin types IV, V, and VI could include postinflammatory hyperpigmentation, postinflammatory hypopigmentation, keloidal scarring, and hypertrophic scarring.

The Food and Drug Administration has conducted postapproval safety studies in Fitzpatrick skin types IV (brown), V (dark brown), and VI (deepest brown to black) for nine dermal fillers, including Restylane, Perlane, and Sculptra, Dr. Taylor said.

Data from three postapproval studies of three fillers each showed that none of the patients with skin of color had hypersensitivity reactions or developed keloids after one or two injections of any of the fillers. Patients in the studies were followed for up to 6 months, approximately.

Overall, 20 (6%) of the 369 patients across the studies developed hyperpigmentation, and 1 developed hypopigmentation, Dr. Taylor said.

“The pigmentation changes were very subtle,” she said.

Changes in pigmentation after injecting fillers in skin or color patients may be due to injection techniques, the use of concomitant anesthesia, or the specific product, Dr. Taylor said.

She advised physicians to look carefully at a patient’s skin prior to injecting any filler to document any pigmentation that was already present to help determine sensitivity and guide their injections techniques accordingly.

There were limitations to the postapproval studies, including the lack of controls and relatively short-term follow-up, and the need for more data.

“But what we can say now is that it’s very important that you warn your patients about the possibility of postinflammatory hyperpigmentation in particular, although hypopigmentation can occur,” Dr. Taylor said. Inform patients that there is a theoretical risk of keloidal scarring, but there have been no reports of keloids in the literature, she added.

To reduce the risk of hyperpigmentation, try a linear threading technique or injecting a bit more deeply to reduce the risk of hyperpigmentation, and note any pigmentation changes over a long-term follow-up period, she said.

Dr. Taylor has served as an investigator, speaker, and/or advisory board member for Allergan, Bioform, Genzyme, Johnson & Johnson, Medicis, Mentor, and Merz.

_{Image above is of Dr. Susan Taylor/Photo Credit: Heidi Splete}

ORLANDO, Fla. – Growing numbers of patients with deeper skin tones are seeking cosmetic procedures involving injectable fillers.

“Many women of color do not have fine lines and wrinkles; they have loss of volume of the skin with

descent of the malar fat pads, prominence of the nasolabial folds, and prominence of the tear troughs, so those are the very areas that are appropriate for injections in women with skin of color, and men as well,” said Dr. Susan Taylor at the Orlando Dermatology Aesthetic and Clinical Conference.

Dr. Taylor, who helped to establish the Skin of Color Center at St. Luke’s–Roosevelt Hospital Center (N.Y.), is now in private practice in Philadelphia. She reviewed the characteristics of aging in patients with skin of color and evidence for the safe use of fillers in these patients.

Patients with skin of color often appear about 10 years younger than white patients of the same age, Dr. Taylor noted. As patients with skin of color age, they tend to have fewer fine and deep rhytids than white patients. But patients with deeper skin tones in their 40s and 50s do experience gravity-dependent changes and volume loss, as well as skeletal changes and soft tissue changes. Thus, these transformations lend themselves to treatment with injectable fillers.

“The options for your skin of color patients are the same options that you have for Caucasian patients,” Dr. Taylor said.

But is it just as safe for persons of color as it is for patients with fair skin? “We know that keloidal scarring develops 3-18 times as often in African American patients as in Caucasian patients,” said Dr. Taylor.

Potential adverse events from soft tissue fillers in patients with Fitzpatrick skin types IV, V, and VI could include postinflammatory hyperpigmentation, postinflammatory hypopigmentation, keloidal scarring, and hypertrophic scarring.

The Food and Drug Administration has conducted postapproval safety studies in Fitzpatrick skin types IV (brown), V (dark brown), and VI (deepest brown to black) for nine dermal fillers, including Restylane, Perlane, and Sculptra, Dr. Taylor said.

Data from three postapproval studies of three fillers each showed that none of the patients with skin of color had hypersensitivity reactions or developed keloids after one or two injections of any of the fillers. Patients in the studies were followed for up to 6 months, approximately.

Overall, 20 (6%) of the 369 patients across the studies developed hyperpigmentation, and 1 developed hypopigmentation, Dr. Taylor said.

“The pigmentation changes were very subtle,” she said.

Changes in pigmentation after injecting fillers in skin or color patients may be due to injection techniques, the use of concomitant anesthesia, or the specific product, Dr. Taylor said.

She advised physicians to look carefully at a patient’s skin prior to injecting any filler to document any pigmentation that was already present to help determine sensitivity and guide their injections techniques accordingly.

There were limitations to the postapproval studies, including the lack of controls and relatively short-term follow-up, and the need for more data.

“But what we can say now is that it’s very important that you warn your patients about the possibility of postinflammatory hyperpigmentation in particular, although hypopigmentation can occur,” Dr. Taylor said. Inform patients that there is a theoretical risk of keloidal scarring, but there have been no reports of keloids in the literature, she added.

To reduce the risk of hyperpigmentation, try a linear threading technique or injecting a bit more deeply to reduce the risk of hyperpigmentation, and note any pigmentation changes over a long-term follow-up period, she said.

Dr. Taylor has served as an investigator, speaker, and/or advisory board member for Allergan, Bioform, Genzyme, Johnson & Johnson, Medicis, Mentor, and Merz.

_{Image above is of Dr. Susan Taylor/Photo Credit: Heidi Splete}