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A Multicenter Study of the Safety and Effectiveness of Hyaluronic Acid with a Cohesive Polydensified Matrix for Treatment of Nasolabial Folds in Subjects with Fitzpatrick Skin Types IV, V, and VI

Downie, Jeanine B. M.D.; Grimes, Pearl E. M.D.; Callender, Valerie D. M.D.

Plastic and Reconstructive Surgery: October 2013 - Volume 132 - Issue 4S-2 - p 41S–47S
doi: 10.1097/PRS.0b013e318299ff53
Cosmetic: Original Articles

Background: Although the use of the hyaluronic acid with cohesive polydensified matrix hyaluronic acid has been well explored in subjects with lighter skin (i.e., Fitzpatrick skin types I, II, and III), further exploration in subjects with Fitzpatrick skin types IV, V, and IV is warranted. The primary purpose of the study was to assess the safety of a cohesive polydensified matrix hyaluronic acid in the correction of nasolabial folds in subjects with Fitzpatrick skin types IV, V and VI, especially assessment of hyperpigmentation, hypopigmentation, and scarring. Effectiveness was also assessed.

Methods: A total of 93 subjects were enrolled in this 24-week investigation at three sites in the United States. All were injected bilaterally for nasolabial fold correction with cohesive polydensified matrix hyaluronic acid. Assessments included the recording of adverse events; injected volumes; wrinkle severity ratings; and global aesthetic improvement by evaluating investigators, treating investigators, and study subjects.

Results: Injection of cohesive polydensified matrix hyaluronic acid for the treatment of nasolabial folds in subjects with Fitzpatrick skin types IV, V, and VI showed no evidence of an association with hypopigmentation, hyperpigmentation, or scarring. Adverse events reported were typical of dermal filler injections with respect to type, rate, duration, and severity.

Conclusion: Cohesive polydensified matrix hyaluronic acid is a safe and well-tolerated dermal filler for subjects with Fitzpatrick skin types IV, V, and VI.

Montclair, N.J.; Los Angeles, Calif.; Washington, D.C.; and Glenn Dale, Md.

From private practice; the Vitiligo and Pigmentation Institute of Southern California; the Department Dermatology, University of California, Los Angeles; Howard University School of Medicine; and the Callender Skin and Laser Center.

Received for publication March 5, 2013; accepted April 30, 2013.

Disclosure: Dr. Callender is a member of the Merz Aesthetics Medical Faculty; she has received compensation from Merz Aesthetics for presentations to members of the medical community. Drs. Downie and Grimes have no financial interests to disclose. Merz Aesthetics supplied necessary materials for this study to investigators, including the hyaluronic acid Belotero Balance. In addition, Merz Aesthetics supported editorial development of this article.

Jeanine B. Downie, M.D., 51 Park Street, Montclair, N.J. 07042,

©2013American Society of Plastic Surgeons