12-month controlled study in the United States of the safety and efficacy of a permanent 2.5% polyacrylamide hydrogel soft-tissue filler

Rhoda S. Narins, William P. Coleman, Rodney Rohrich, Gary Monheit, Richard Glogau, Fredric Brandt, Suzanne Bruce, Lawrence Colen, Steven Dayan, Ian Jackson, Corey Maas, Alexander Rivkin, Anthony Sclafani, Joan C. Spivak

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Objective To evaluate the safety and efficacy of a 2.5% polyacrylamide hydrogel in the aesthetic enhancement of nasolabial folds. METHODS AND MATERIALS The safety and efficacy of a polyacrylamide hydrogel were compared with those of nonanimal stabilized hyaluronic acid (NASHA) in 315 subjects in a double-blind, randomized, multicenter, noninferiority trial with a 12-month follow-up. The primary efficacy end point was mean change in Wrinkle Assessment Scale (WAS) scores at 6 months. The primary safety end point was rate of serious adverse events (AEs) through 12 months after treatment. RESULTS Polyacrylamide hydrogel was as effective as NASHA, and effectiveness persisted throughout the 12-month follow-up. Treatment-related AEs occurred with equal incidence; most were mild to moderate, transient, and related to injection procedure. One serious AE (infection) was thought to be related to treatment with polyacrylamide hydrogel; it resolved within 5 days after appropriate treatment. CONCLUSION This 2.5% polyacrylamide hydrogel offers promise as a long-lasting soft tissue filler. It is well tolerated, as effective as NASHA in correction of nasolabial folds, and persistent. Longer evaluation is required to evaluate longer-term safety and demonstrate duration of effect beyond 12 months. This study was supported by Contura, Soeborg, Denmark. Joan C. Spivak was paid by the sponsor for her editorial assistance.

Original languageEnglish (US)
Pages (from-to)1819-1830
Number of pages12
JournalDermatologic Surgery
Volume36
Issue numberSUPPL. 3
DOIs
StatePublished - Nov 2010

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Safety
Hyaluronic Acid
Nasolabial Fold
Denmark
Therapeutics
Esthetics
Multicenter Studies
polyacrylamide gels
Injections
Incidence
Infection

ASJC Scopus subject areas

  • Dermatology
  • Surgery

Cite this

Narins, R. S., Coleman, W. P., Rohrich, R., Monheit, G., Glogau, R., Brandt, F., ... Spivak, J. C. (2010). 12-month controlled study in the United States of the safety and efficacy of a permanent 2.5% polyacrylamide hydrogel soft-tissue filler. Dermatologic Surgery, 36(SUPPL. 3), 1819-1830. https://doi.org/10.1111/j.1524-4725.2010.01736.x

12-month controlled study in the United States of the safety and efficacy of a permanent 2.5% polyacrylamide hydrogel soft-tissue filler. / Narins, Rhoda S.; Coleman, William P.; Rohrich, Rodney; Monheit, Gary; Glogau, Richard; Brandt, Fredric; Bruce, Suzanne; Colen, Lawrence; Dayan, Steven; Jackson, Ian; Maas, Corey; Rivkin, Alexander; Sclafani, Anthony; Spivak, Joan C.

In: Dermatologic Surgery, Vol. 36, No. SUPPL. 3, 11.2010, p. 1819-1830.

Research output: Contribution to journalArticle

Narins, RS, Coleman, WP, Rohrich, R, Monheit, G, Glogau, R, Brandt, F, Bruce, S, Colen, L, Dayan, S, Jackson, I, Maas, C, Rivkin, A, Sclafani, A & Spivak, JC 2010, '12-month controlled study in the United States of the safety and efficacy of a permanent 2.5% polyacrylamide hydrogel soft-tissue filler', Dermatologic Surgery, vol. 36, no. SUPPL. 3, pp. 1819-1830. https://doi.org/10.1111/j.1524-4725.2010.01736.x
Narins, Rhoda S. ; Coleman, William P. ; Rohrich, Rodney ; Monheit, Gary ; Glogau, Richard ; Brandt, Fredric ; Bruce, Suzanne ; Colen, Lawrence ; Dayan, Steven ; Jackson, Ian ; Maas, Corey ; Rivkin, Alexander ; Sclafani, Anthony ; Spivak, Joan C. / 12-month controlled study in the United States of the safety and efficacy of a permanent 2.5% polyacrylamide hydrogel soft-tissue filler. In: Dermatologic Surgery. 2010 ; Vol. 36, No. SUPPL. 3. pp. 1819-1830.
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abstract = "Objective To evaluate the safety and efficacy of a 2.5{\%} polyacrylamide hydrogel in the aesthetic enhancement of nasolabial folds. METHODS AND MATERIALS The safety and efficacy of a polyacrylamide hydrogel were compared with those of nonanimal stabilized hyaluronic acid (NASHA) in 315 subjects in a double-blind, randomized, multicenter, noninferiority trial with a 12-month follow-up. The primary efficacy end point was mean change in Wrinkle Assessment Scale (WAS) scores at 6 months. The primary safety end point was rate of serious adverse events (AEs) through 12 months after treatment. RESULTS Polyacrylamide hydrogel was as effective as NASHA, and effectiveness persisted throughout the 12-month follow-up. Treatment-related AEs occurred with equal incidence; most were mild to moderate, transient, and related to injection procedure. One serious AE (infection) was thought to be related to treatment with polyacrylamide hydrogel; it resolved within 5 days after appropriate treatment. CONCLUSION This 2.5{\%} polyacrylamide hydrogel offers promise as a long-lasting soft tissue filler. It is well tolerated, as effective as NASHA in correction of nasolabial folds, and persistent. Longer evaluation is required to evaluate longer-term safety and demonstrate duration of effect beyond 12 months. This study was supported by Contura, Soeborg, Denmark. Joan C. Spivak was paid by the sponsor for her editorial assistance.",
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AU - Brandt, Fredric

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AU - Colen, Lawrence

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