Clinical evidence

Fibroblast Therapy for Smile Lines: What Clinical Trials Found

A double-blind trial with 372 patients and a phase III trial with 215 patients studied fibroblast injections for nasolabial folds and facial contour. Here is what they found.

Medical director: Dr. Joan Tuareg Chávez Medina, MD · Mexican medical licence 12033364

Quick answer

In a 2012 trial with 372 patients, 64% of those who received autologous fibroblasts improved their smile lines by at least one point according to blinded evaluators, versus 36% with placebo. A phase III trial with 215 patients also found more improvement than placebo. The fibroblasts studied were autologous.

Why fibroblasts

Fibroblasts are the cells of the dermis that produce collagen and elastin. With age and sun exposure they become fewer and less active, and the skin loses firmness.

What the trials found

  • 372 patients (2012): according to blinded evaluators, 64% improved with fibroblasts versus 36% with placebo at 6 months.
  • 215 patients (2007): significantly more improvement than placebo, with response rates of 75% at 9 months and 82% at 12 months.

What it means for you

Some of the strongest trials in regenerative aesthetics, with an important caveat about the type of product. See skin rejuvenation.

Studies cited

Double-blind, placebo-controlled randomized trial · 372 patients · 2012

Smith SR, et al. Dermatologic Surgery

A multicenter, double-blind, placebo-controlled trial of autologous fibroblast therapy for the treatment of nasolabial fold wrinkles

Reported result: At 6 months, 78% of patients treated with autologous fibroblasts and 48% with placebo improved by at least one point in their own assessment; according to blinded evaluators, 64% vs 36% (p < 0.001). Adverse events were generally mild.

Phase III placebo-controlled trial · 215 patients · 2007

Weiss RA, et al. Dermatologic Surgery

Autologous cultured fibroblast injection for facial contour deformities: a prospective, placebo-controlled, Phase III clinical trial

Reported result: Live fibroblasts produced significantly greater improvement than placebo at 6 months (p < 0.0001). At 9 and 12 months, response rates in the treated group were 75.0% and 81.6%. No serious treatment-related adverse events.