Filler, Toxin Combo Best Enhances Lower Face

PHOENIX — Dermatologists may be under the clinical impression that botulinum toxin is better suited for the upper face, while fillers are the treatment of choice for the lower face.

However, as demonstrated in a previous upper-face study, the combined use of toxin and filler gave not only a superior aesthetic result but virtually doubled the duration of aesthetic response (Dermatol. Surg. 2003;29:802-9).

To elucidate these findings, Dr. Jean Carruthers and her husband Dr. Alastair Carruthers designed a lower-face study at three clinical sites. Along with Dr. Gary D. Monheit, they recruited 30 women from each site, for a total of 90, for the parallel group study.

They randomized 30 patients to receive onabotulinumtoxinA (Botox, Allergan), 30 to Juvéderm Ultra and/or Juvéderm Ultra Plus (hyaluronic acid, Allergen), and the remaining 30 patients to a combination of both treatments.

They first assessed the 35- to 55-year-old patients at baseline. Each patient was treated once and allowed one touch-up session of filler, but as many treatments with lower-face botulinum toxin as they felt they needed. A blinded rater and a principal investigator followed clinical outcomes over 6 months.

Lip fullness was rated superior in the combination group, Dr. Monheit said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery. Juvéderm alone was found more effective than botulinum toxin alone at increasing ratings on the lip-fullness scale. Photographic analysis confirmed the investigator evaluation.

In terms of oral commissure improvements, the combination outperformed both of the single treatments, although the “filler almost matched it in most aspects,” said Dr. Monheit of the departments of dermatology and ophthalmology at the University of Alabama at Birmingham.

Dr. Jean Carruthers is clinical professor of ophthalmology at the University of British Columbia, Vancouver. Dr. Alastair Carruthers is clinical professor in the department of dermatology at the same university. Investigators asked participants to purse their lips at each assessment. “We took smooch-pose photos to look at perioral lines,” Dr. Monheit said. “We also took grimace photos to show the power of the [depressor anguli oris] muscle.” At maximal contraction, the combination yielded better results again.

The investigators and patients also completed satisfaction questionnaires. They rated multiple areas. “Botox alone pretty well lagged behind [on the] investigator's lip satisfaction questionnaire,” the investigators noted. “The patient questionnaire had pretty much the same results: The combination and filler did best, and the toxin lagged behind.”

At the conclusion of the study, the combination treatment group fared better than the filler or the toxin groups alone on most outcome measures, including lip fullness, oral commissure severity, and perioral line improvement. In addition, subjective patient satisfaction and objective investigator satisfaction rankings were highest in the combined group. Overall, the results in the combined group were better, and the longevity of response was longer. “This is a confirmation of what we do on an everyday basis,” Dr. Monheit said.

Swelling, bruising, asymmetry, and lumps were adverse events recorded in patient diaries and reported by investigators, but these “minor adverse events were rarely noted in subjects with combination treatment,” Dr. Monheit said.

Disclosures: This investigator-initiated study was funded by Allergan. The company had no input on study design or outcome, according to the investigators. Dr. Jean and Alastair Carruthers are both consultants and researchers for Allergan, Merz Pharmaceuticals, and BioForm Medical. Dr. Monheit is a researcher and consultant for Allergan, Genzyme, and Johnson & Johnson, as well as a researcher for Dermik Laboratories, Inamed Aesthetics, and ColBar LifeScience.

PHOENIX — Dermatologists may be under the clinical impression that botulinum toxin is better suited for the upper face, while fillers are the treatment of choice for the lower face.

However, as demonstrated in a previous upper-face study, the combined use of toxin and filler gave not only a superior aesthetic result but virtually doubled the duration of aesthetic response (Dermatol. Surg. 2003;29:802-9).

To elucidate these findings, Dr. Jean Carruthers and her husband Dr. Alastair Carruthers designed a lower-face study at three clinical sites. Along with Dr. Gary D. Monheit, they recruited 30 women from each site, for a total of 90, for the parallel group study.

They randomized 30 patients to receive onabotulinumtoxinA (Botox, Allergan), 30 to Juvéderm Ultra and/or Juvéderm Ultra Plus (hyaluronic acid, Allergen), and the remaining 30 patients to a combination of both treatments.

They first assessed the 35- to 55-year-old patients at baseline. Each patient was treated once and allowed one touch-up session of filler, but as many treatments with lower-face botulinum toxin as they felt they needed. A blinded rater and a principal investigator followed clinical outcomes over 6 months.

Lip fullness was rated superior in the combination group, Dr. Monheit said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery. Juvéderm alone was found more effective than botulinum toxin alone at increasing ratings on the lip-fullness scale. Photographic analysis confirmed the investigator evaluation.

In terms of oral commissure improvements, the combination outperformed both of the single treatments, although the “filler almost matched it in most aspects,” said Dr. Monheit of the departments of dermatology and ophthalmology at the University of Alabama at Birmingham.

Dr. Jean Carruthers is clinical professor of ophthalmology at the University of British Columbia, Vancouver. Dr. Alastair Carruthers is clinical professor in the department of dermatology at the same university. Investigators asked participants to purse their lips at each assessment. “We took smooch-pose photos to look at perioral lines,” Dr. Monheit said. “We also took grimace photos to show the power of the [depressor anguli oris] muscle.” At maximal contraction, the combination yielded better results again.

The investigators and patients also completed satisfaction questionnaires. They rated multiple areas. “Botox alone pretty well lagged behind [on the] investigator's lip satisfaction questionnaire,” the investigators noted. “The patient questionnaire had pretty much the same results: The combination and filler did best, and the toxin lagged behind.”

At the conclusion of the study, the combination treatment group fared better than the filler or the toxin groups alone on most outcome measures, including lip fullness, oral commissure severity, and perioral line improvement. In addition, subjective patient satisfaction and objective investigator satisfaction rankings were highest in the combined group. Overall, the results in the combined group were better, and the longevity of response was longer. “This is a confirmation of what we do on an everyday basis,” Dr. Monheit said.

Swelling, bruising, asymmetry, and lumps were adverse events recorded in patient diaries and reported by investigators, but these “minor adverse events were rarely noted in subjects with combination treatment,” Dr. Monheit said.

Disclosures: This investigator-initiated study was funded by Allergan. The company had no input on study design or outcome, according to the investigators. Dr. Jean and Alastair Carruthers are both consultants and researchers for Allergan, Merz Pharmaceuticals, and BioForm Medical. Dr. Monheit is a researcher and consultant for Allergan, Genzyme, and Johnson & Johnson, as well as a researcher for Dermik Laboratories, Inamed Aesthetics, and ColBar LifeScience.

PHOENIX — Dermatologists may be under the clinical impression that botulinum toxin is better suited for the upper face, while fillers are the treatment of choice for the lower face.

However, as demonstrated in a previous upper-face study, the combined use of toxin and filler gave not only a superior aesthetic result but virtually doubled the duration of aesthetic response (Dermatol. Surg. 2003;29:802-9).

To elucidate these findings, Dr. Jean Carruthers and her husband Dr. Alastair Carruthers designed a lower-face study at three clinical sites. Along with Dr. Gary D. Monheit, they recruited 30 women from each site, for a total of 90, for the parallel group study.

They randomized 30 patients to receive onabotulinumtoxinA (Botox, Allergan), 30 to Juvéderm Ultra and/or Juvéderm Ultra Plus (hyaluronic acid, Allergen), and the remaining 30 patients to a combination of both treatments.

They first assessed the 35- to 55-year-old patients at baseline. Each patient was treated once and allowed one touch-up session of filler, but as many treatments with lower-face botulinum toxin as they felt they needed. A blinded rater and a principal investigator followed clinical outcomes over 6 months.

Lip fullness was rated superior in the combination group, Dr. Monheit said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery. Juvéderm alone was found more effective than botulinum toxin alone at increasing ratings on the lip-fullness scale. Photographic analysis confirmed the investigator evaluation.

In terms of oral commissure improvements, the combination outperformed both of the single treatments, although the “filler almost matched it in most aspects,” said Dr. Monheit of the departments of dermatology and ophthalmology at the University of Alabama at Birmingham.

Dr. Jean Carruthers is clinical professor of ophthalmology at the University of British Columbia, Vancouver. Dr. Alastair Carruthers is clinical professor in the department of dermatology at the same university. Investigators asked participants to purse their lips at each assessment. “We took smooch-pose photos to look at perioral lines,” Dr. Monheit said. “We also took grimace photos to show the power of the [depressor anguli oris] muscle.” At maximal contraction, the combination yielded better results again.

The investigators and patients also completed satisfaction questionnaires. They rated multiple areas. “Botox alone pretty well lagged behind [on the] investigator's lip satisfaction questionnaire,” the investigators noted. “The patient questionnaire had pretty much the same results: The combination and filler did best, and the toxin lagged behind.”

At the conclusion of the study, the combination treatment group fared better than the filler or the toxin groups alone on most outcome measures, including lip fullness, oral commissure severity, and perioral line improvement. In addition, subjective patient satisfaction and objective investigator satisfaction rankings were highest in the combined group. Overall, the results in the combined group were better, and the longevity of response was longer. “This is a confirmation of what we do on an everyday basis,” Dr. Monheit said.

Swelling, bruising, asymmetry, and lumps were adverse events recorded in patient diaries and reported by investigators, but these “minor adverse events were rarely noted in subjects with combination treatment,” Dr. Monheit said.

Disclosures: This investigator-initiated study was funded by Allergan. The company had no input on study design or outcome, according to the investigators. Dr. Jean and Alastair Carruthers are both consultants and researchers for Allergan, Merz Pharmaceuticals, and BioForm Medical. Dr. Monheit is a researcher and consultant for Allergan, Genzyme, and Johnson & Johnson, as well as a researcher for Dermik Laboratories, Inamed Aesthetics, and ColBar LifeScience.